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GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM) recallZ-1325-2023 · Medtronic Sofamor Danek USA Inc · initiated Feb 8, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Sofamor Danek USA Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

FDA root cause category: Process control

What the company is doing

Medtronic Sofamor Danek notified customers of the recall on about 02/08/2023, via letter. Customers were instructed to identify and quarantine any affected products, return any affected products, complete and return the Customer Confirmation Form, and provide the letter to all personnel that should be aware or where affected products have been transferred/distributed.

Recall details

Recall number
Z-1325-2023
Status
Open, Classified
Initiated by the company
Feb 8, 2023
Posted by the FDA
Apr 4, 2023
Recalling firm
Medtronic Sofamor Danek USA Inc
Quantity
2987 units
Product code
MBP
FDA submissions
K051195
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, United Kingdom, Viet Nam.

Product description

Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090; c) DBM T42090INT 1.5CMX1.5CM FLEX GRAFTON, REF T42090INT; d) DBM T42100 2.5CMX10CM FLEX GRAFTON, REF T42100; e) DBM T42100AUS 2.5CMX10CM FLEX GRAFTON, REF T42100AUS; f) DBM T42100INT 2.5CMX10CM FLEX GRAFTON, REF T42100INT; g) DBM T42110 2.5CMX5CM FLEXGRAFTON, REF T42110; h) DBM T42110AUS 2.5CMX5CM FLEX GRAFTON, REF T42110AUS; i) DBM T42110INT 2.5CMX5CM FLEXGRAFTON, REF T42110INT; j) DBM T42150INT 5CM X 5CM FLEX GRAFTON, REF T42150INT; Demineralized Bone Matrix (DBM) product

Code information (models, lots, serial numbers)

Show the full code information (37k characters)

a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090, GTIN 00613994961006, Serial Numbers: A50360, A52104, A55429; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090, GTIN 00643169122994, Serial Numbers: A40174-066, A40174-067, A40174-068, A40174-069, A40174-070, A40174-071, A40174-072, A40174-073, A40174-074, A40174-075, A40174-076, A40174-077, A40174-078, A40174-079, A42594-022, A42594-023, A42594-024, A42594-025, A42594-026, A42594-027, A42594-028, A42594-029, A42594-030, A42594-031, A42594-032, A42594-033, A42594-034, A42594-035, A42594-036, A42594-037, A42890-011, A42890-012, A42890-013, A42890-014, A42890-015, A42890-016, A42890-017, A42890-018, A42890-019, A42890-020, A42890-021, A42890-022, A42890-023, A42890-024, A43119-101, A43119-102, A43119-103, A43119-104, A43119-105, A43220-011, A43220-012, A44574-011, A44574-012, A44574-013, A44574-014, A44574-015, A44574-016, A44616-011, A44616-012, A44616-013, A44616-014, A44616-015, A44616-016, A44616-017, A44616-018, A44616-019, A44616-020, A44616-021, A44616-022, A44616-023, A44616-024, A44616-025, A44616-026, A44616-027, A44616-028, A44616-029, A44616-030, A44616-031, A44616-032, A44616-033, A44616-034, A44616-035, A44704-011, A44704-012, A44704-013, A44704-014, A44704-015, A44704-016, A44704-017, A44704-018, A44704-019, A44704-020, A44704-021, A44704-022, A44704-023, A44704-024, A45275-011, A45275-012, A45275-013, A45275-014, A45275-015, A45275-016, A45275-017, A45275-018, A45275-019, A45275-020, A45275-021, A45275-022, A45275-023, A45275-024, A45275-025, A45275-026, A45275-027, A45275-028, A45275-029, A45275-030, A45275-031, A45275-032, A45275-033, A45275-034, A45275-035, A45544-011, A45544-012, A45544-013, A45544-014, A45544-015, A45544-016, A45544-017, A45544-018, A45544-019, A45544-020, A45544-021, A45544-022, A45544-023, A45544-024, A45544-025, A46162-011, A46162-012, A46162-013, A46162-014, A46162-015, A46162-016, A46162-017, A46162-018, A46162-019, A46162-020, A46162-021, A46162-022, A46162-023, A46162-024, A46537-011, A46537-012, A46537-013, A46537-014, A46537-015, A46537-016, A46537-017, A46537-018, A46537-019, A46537-020, A46537-021, A46537-022, A46537-023, A46537-024, A46537-025, A46537-026, A46711-024, A46711-025, A46711-026, A46711-027, A46711-028, A46711-029, A46711-030, A46711-031, A46711-032, A46711-033, A46711-034, A46711-035, A46711-036, A46711-037, A47573-011, A47573-012, A47573-013, A47573-014, A48312-011, A48312-012, A48312-013, A48312-014, A48312-015, A48312-016, A48312-017, A48312-018, A48312-019, A48472-011, A48472-012, A48472-013, A48472-014, A48472-015, A48472-016, A48472-017, A48472-018, A48472-019, A48472-020, A48472-021, A48472-022, A48759-011, A48759-012, A48759-013, A48759-014, A48759-015, A48759-016, A48759-017, A48759-018, A48759-019, A48759-020, A48759-021, A48759-023, A48759-024, A48759-025, A48759-026, A49927-011, A49927-012, A49927-013, A49927-014, A49927-015, A49927-016, A49927-017, A49927-018, A49927-019, A49927-020, A49927-021, A49927-022, A49927-023, A51087-011, A51087-012, A51087-013, A51087-014, A51087-015, A51087-016, A51087-017, A51087-018, A51102-054, A51102-055, A51102-056, A51102-057, A51102-058, A51102-059, A51102-060, A51102-061, A52712-082, A52712-083, A52712-084, A52712-085, A52712-086, A52712-087, A52712-088, A52712-089, A52712-090, A52712-091, A52712-092, A52712-093, A52712-094, A52712-095, A52712-096, A52712-097, A52712-098, A52712-099, A52712-100, A53148-011, A53148-012, A53148-013, A53148-014, A53148-015, A53284-026, A53284-027, A53284-028, A53284-029, A53284-030, A53284-031, A53284-032, A53284-033, A53284-034, A53284-035, A53284-036, A53284-037, A53284-038, A53284-039, A53284-040, A53284-041, A53284-042, A53284-043, A53284-044, A53284-045, A53284-046, A53770-011, A53770-012, A53770-013, A53770-014, A53770-015, A53770-016, A53770-017, A53770-018, A53770-019, A53770-020, A53770-021, A53770-022, A53770-023, A54399-043, A54399-044, A54399-045, A54399-046, A54399-047, A54399-048, A54399-049, A54399-050, A54399-051, A54399-052, A54399-053, A54399-054, A54399-055, A54399-056, A54399-057, A55095-050, A55095-051, A55095-052, A55095-053, A55095-054, A55095-055, A55095-056, A55095-057, A55095-058, A55095-059, A55095-060, A55095-061, A55095-062, A55095-063, A55095-064, A55095-065, A55095-066, A55095-067; c) DBM T42090INT 1.5CMX1.5CM FLEX GRAFTON, REF T42090INT, GTIN 00643169964877, Serial Numbers: A42232-041, A42232-042, A42232-043, A42232-044, A42232-045, A42232-046, A42232-047, A42232-048, A42232-049, A42232-050, A42232-051, A42232-052, A42232-053, A42232-054, A42232-055, A42232-056, A42232-057, A42232-058, A42232-059, A42232-060, A42232-061, A42232-062, A42232-063, A42851-038, A42851-039, A42851-040, A42851-041, A42851-042, A42851-043, A42851-044, A42851-045, A42851-046, A42851-047, A42851-048, A42851-049, A42851-050, A42851-051, A42851-052, A43708-049, A43708-050, A43708-051, A43708-052, A43708-053, A43708-054, A43708-055, A43708-056, A43708-057, A43708-058, A43708-059, A43708-060, A43708-061, A43708-062, A43708-063, A43708-064, A43708-065, A43708-066, A43708-067, A43708-068, A43708-069, A43708-070, A43708-071, A43708-072, A43708-073, A43708-074, A43708-075, A43708-076, A43708-077, A43708-078, A43708-079, A43708-080, A43708-082, A43708-083, A43708-084, A43708-085, A43708-086, A43708-087, A43708-088, A43708-089, A43708-090, A43708-092, A43708-093, A43708-094, A43708-095, A43708-096, A43708-099, A43708-101, A43708-102, A43708-103, A43708-104, A44398-011, A44398-012, A44398-013, A44398-014, A44398-015, A44398-016, A44398-017, A44398-018, A44398-019, A44398-020, A44398-021, A44398-022, A44398-023, A44398-024, A44398-025, A44398-026, A44398-027, A44398-028, A44398-029, A44398-030, A44398-031, A44398-032, A44398-033, A44398-034, A44398-035, A44704-025, A44704-026, A44704-027, A44704-028, A44704-029, A44704-030, A44704-031, A44704-032, A44704-033, A44704-034, A44704-035, A44704-036, A44704-037, A44704-038, A45772-011, A45772-012, A45772-013, A45772-014, A45772-015, A45826-011, A45826-012, A45826-013, A45826-014, A45898-023, A45898-024, A45898-025, A45898-026, A47573-029, A47832-021, A48759-039, A52104-039, A52104-040, A52104-041, A52104-042, A52104-043, A52104-044, A52104-045, A52104-047, A52104-048, A52104-049, A52104-050, A52104-051, A52104-052, A52104-053, A52104-054, A52104-055, A53050-011, A53050-012, A53050-013, A53050-014, A53050-015, A53050-016, A53050-017, A53050-018, A53050-019, A53050-020, A55429-021; d) DBM T42100 2.5CMX10CM FLEX GRAFTON, REF T42100, GTIN 00643169123007, Serial Numbers: A41864-011, A41864-012, A41864-013, A41864-014, A41864-015, A41864-016, A41864-017, A41864-018, A41864-019, A41864-020, A41864-021, A42890-025, A42890-026, A42890-027, A42890-028, A42890-029, A42890-030, A42890-031, A42890-032, A42890-033, A42890-034, A42890-035, A42890-036, A42890-037, A42890-038, A42964-021, A42964-022, A42964-023, A42964-024, A42964-025, A42964-026, A42964-027, A42964-028, A42964-029, A42972-061, A42972-062, A42972-063, A42972-064, A42972-065, A42972-066, A42972-067, A42972-068, A42972-069, A42972-070, A42972-071, A42972-072, A42972-073, A42972-074, A42972-075, A42972-076, A43119-106, A43119-107, A43119-108, A43119-109, A43119-110, A43119-111, A43119-112, A43119-113, A43119-114, A43119-115, A43119-116, A43119-117, A43119-118, A43155-016, A43155-017, A43155-018, A43155-019, A43155-020, A43155-021, A43155-022, A43155-023, A43155-024, A43155-025, A43155-026, A43281-030, A43281-031, A43281-032, A43281-033, A43281-034, A43281-035, A43281-036, A43281-037, A43281-038, A43281-039, A43281-040, A43403-011, A43403-012, A43403-013, A43403-014, A43403-015, A43403-016, A43403-017, A43403-018, A43403-019, A43403-020, A43403-021, A43403-022, A43403-023, A43403-024, A43403-025, A43708-105, A43708-106, A43708-107, A43708-108, A43708-109, A43708-110, A44100-011, A44100-012, A44100-013, A44100-014, A44100-015, A44100-016, A44100-017, A44100-018, A44100-019, A44100-020, A44100-021, A44100-022, A44100-023, A44100-024, A44100-025, A44118-011, A44118-012, A44118-013, A44118-014, A44118-015, A44118-016, A44118-017, A44118-018, A44118-019, A44118-020, A44118-021, A44118-022, A44118-023, A44118-024, A44290-011, A44290-012, A44290-013, A44290-014, A44290-015, A44290-016, A44290-017, A44290-018, A44290-019, A44290-020, A44290-021, A44290-022, A44290-023, A44290-024, A44290-025, A44290-026, A44311-011, A44311-012, A44311-013, A44311-014, A44311-015, A44311-016, A44311-017, A44311-018, A44311-019, A44311-020, A44311-021, A44311-022, A44311-023, A44311-024, A44311-025, A44372-129, A44372-130, A44372-131, A44372-132, A44372-133, A44372-134, A44372-135, A44372-136, A44372-137, A44372-138, A44372-139, A44372-140, A44372-141, A44372-142, A44372-143, A44412-060, A44412-061, A44412-062, A44412-063, A44412-064, A44412-065, A44412-066, A44412-067, A44412-068, A44412-069, A44412-070, A44412-071, A44412-072, A44412-073, A44412-074, A44655-046, A44655-047, A44655-048, A44655-049, A44655-050, A44655-051, A44655-052, A44655-053, A44655-054, A44655-055, A44655-056, A44655-057, A44655-058, A44764-011, A44764-012, A44764-013, A44764-014, A44764-015, A44764-016, A44764-017, A44764-018, A44764-019, A44764-020, A45256-011, A45256-012, A45256-013, A45256-014, A45256-015, A45256-016, A45256-017, A45256-018, A45256-019, A45256-020, A45256-021, A45256-022, A45256-023, A45256-024, A45256-025, A45281-117, A45281-118, A45281-119, A45281-120, A45281-121, A45281-122, A45281-123, A45281-124, A45281-125, A45281-126, A45281-127, A45281-128, A45281-129, A45281-130, A45281-131, A45512-011, A45512-012, A45521-011, A45521-012, A45521-013, A45521-014, A45521-015, A45521-016, A45521-017, A45521-018, A45521-019, A45521-020, A45521-021, A45521-022, A45521-023, A45521-024, A45521-025, A45521-026, A45544-026, A45544-027, A45544-028, A45544-029, A45544-030, A45544-031, A45544-032, A45544-033, A45544-034, A45544-035, A45544-036, A45544-037, A45544-038, A45544-039, A45572-033, A45572-034, A45572-035, A45572-036, A45572-037, A45572-038, A45572-039, A45572-040, A45572-041, A45572-042, A45572-043, A45572-044, A45572-045, A45572-046, A45572-047, A45579-021, A45579-022, A45579-023, A45579-024, A45579-025, A45579-026, A45579-027, A45579-028, A45579-029, A45579-030, A45579-031, A45579-032, A45579-033, A45579-034, A45579-035, A45581-036, A45581-037, A45581-038, A45581-039, A45581-040, A45581-041, A45581-042, A45581-043, A45581-044, A45581-045, A45581-046, A45581-047, A45581-048, A45581-049, A45581-050, A45581-051, A45703-011, A45703-012, A45703-013, A45703-014, A45703-015, A45703-016, A45703-017, A45703-018, A45703-019, A45703-020, A45703-021, A45703-022, A45703-023, A45703-024, A45703-025, A45703-026, A45970-011, A45970-012, A45970-013, A45970-014, A45970-015, A45970-016, A45970-017, A45970-018, A45970-019, A45970-020, A45970-021, A45970-022, A45970-023, A45970-024, A45970-025, A45970-026, A46023-031, A46023-032, A46023-033, A46023-034, A46023-035, A46023-036, A46023-037, A46023-038, A46023-039, A46023-040, A46023-041, A46023-042, A46044-058, A46044-059, A46044-060, A46044-061, A46044-062, A46044-063, A46044-064, A46044-065, A46044-066, A46044-067, A46044-068, A46044-069, A46044-070, A46044-071, A46162-025, A46162-026, A46162-027, A46162-028, A46162-029, A46162-030, A46162-031, A46162-032, A46162-033, A46162-034, A46162-035, A46162-036, A46162-037, A46162-038, A46537-027, A46537-028, A46537-029, A46537-030, A46537-031, A46537-032, A46537-033, A46537-034, A46537-035, A46537-036, A46537-037, A46537-038, A46537-039, A46537-040, A46537-041, A46537-042, A46537-043, A46537-044, A46537-045, A46537-046, A46537-047, A46537-048, A46537-049, A46537-050, A46552-011, A46552-012, A46552-013, A46552-014, A46552-015, A46552-016, A46552-017, A46552-018, A46552-019, A46552-020, A46552-021, A46552-022, A46552-023, A46552-024, A46583-011, A46583-012, A46583-013, A46583-014, A46583-015, A46583-016, A46583-017, A46583-018, A46583-019, A46583-020, A46583-021, A46711-038, A46711-039, A46711-040, A46711-041, A46711-042, A46711-043, A46711-044, A46711-045, A46711-046, A46711-047, A46711-048, A46711-049, A46711-050, A46711-051, A46711-052, A46711-053, A46711-054, A46711-055, A46711-056, A46711-057, A46711-058, A46711-059, A46849-127, A46849-129, A46849-130, A46849-131, A46849-132, A46849-133, A46849-134, A46849-135, A46849-136, A46891-042, A46891-043, A46891-044, A46891-045, A46891-046, A46991-031, A46991-032, A46991-033, A46991-034, A46991-035, A46991-036, A46991-037, A46991-038, A46991-039, A46991-040, A46991-041, A46991-042, A46991-043, A46991-044, A46991-045, A47264-011, A47264-012, A47264-013, A47264-014, A47264-015, A47264-016, A47264-017, A47264-018, A47264-019, A47264-020, A47264-021, A47264-022, A47264-023, A47264-024, A47264-025, A47264-026, A47264-027, A47264-028, A47264-029, A47264-030, A47264-031, A47264-032, A47264-033, A47264-034, A47264-035, A47264-036, A47264-037, A47264-038, A47264-039, A47264-040, A47264-041, A47293-136, A47293-137, A47293-138, A47293-139, A47293-140, A47293-141, A47293-142, A47293-143, A47293-144, A47293-145, A47293-146, A47293-147, A47293-148, A47293-149, A47293-150, A47345-011, A47345-012, A47345-013, A47345-014, A47345-015, A47345-016, A47345-017, A47345-018, A47345-019, A47345-020, A47345-021, A47345-022, A47345-023, A47345-024, A47345-025, A47345-026, A47345-027, A47345-028, A47345-029, A47345-030, A47345-031, A47345-032, A47345-033, A47345-034, A47345-035, A47345-036, A47345-037, A47345-038, A47369-011, A47369-012, A47369-013, A47369-014, A47369-015, A47369-016, A47369-017, A47369-018, A47369-019, A47369-020, A47369-021, A47369-022, A47369-023, A47369-024, A47514-024, A47514-025, A47514-026, A47514-027, A47514-028, A47514-029, A47514-030, A47514-031, A47573-015, A47573-016, A47573-017, A47573-018, A47573-019, A47573-020, A47573-021, A47573-022, A47573-023, A47573-024, A47573-025, A47573-026, A47573-027, A47573-028, A47577-036, A47577-037, A47577-038, A47577-039, A47577-040, A47577-041, A47577-042, A47577-043, A47577-044, A47577-045, A47577-046, A47577-047, A47577-048, A47577-049, A47577-050, A47577-051, A47590-029, A47590-030, A47590-031, A47590-032, A47590-033, A47590-034, A47590-035, A47590-036, A47590-037, A47590-038, A47590-039, A47590-040, A47590-041, A47590-042, A47864-017, A47864-018, A47864-019, A47864-020, A47864-021, A47864-022, A47864-023, A47864-024, A47864-025, A47864-026, A47864-027, A47864-028, A47864-029, A47864-030, A47864-031, A47864-032, A47864-033, A47864-034, A47864-035, A47864-036, A47864-037, A47864-038, A47864-039, A47864-040, A47864-041, A48052-011, A48052-012, A48052-013, A48052-014, A48052-015, A48052-016, A48052-017, A48052-018, A48052-019, A48052-020, A48052-021, A48052-022, A48052-023, A48052-024, A48154-011, A48154-012, A48154-013, A48154-014, A48154-015, A48154-016, A48154-017, A48154-018, A48154-019, A48154-020, A48154-021, A48234-011, A48234-012, A48234-013, A48234-014, A48234-016, A48234-017, A48234-018, A48234-019, A48234-020, A48234-021, A48234-022, A48234-023, A48234-024, A48472-023, A48472-024, A48472-025, A48472-026, A48472-027, A48472-028, A48472-029, A48472-030, A48472-031, A48472-032, A48472-033, A48472-034, A48556-011, A48556-012, A48556-013, A48556-014, A48556-015, A48556-016, A48556-017, A48556-018, A48556-019, A48556-020, A48556-021, A48573-077, A48573-078, A48573-079, A48573-080, A48573-081, A48573-082, A48573-083, A48573-084, A48573-085, A48573-086, A48573-087, A48573-088, A48573-089, A48573-090, A48573-091, A48573-092, A48689-011, A48689-012, A48689-013, A48689-014, A48689-015, A48689-016, A48689-017, A48689-018, A48689-019, A48689-020, A48689-021, A48689-022, A48759-027, A48759-028, A48759-029, A48759-030, A48759-031, A48759-032, A48759-033, A48759-034, A48759-035, A48759-036, A48759-037, A48759-038, A48941-011, A48941-012, A48941-013, A48941-014, A48941-015, A48941-016, A48941-017, A48941-018, A48941-019, A48941-020, A48941-021, A49861-049, A49861-050, A49861-052, A49861-053, A49861-054, A49861-055, A49861-056, A49861-057, A49861-058, A49861-059, A49861-060, A49861-061, A49861-063, A49861-064, A49861-065, A49861-066, A49861-067, A49861-068, A49861-069, A49861-070, A49861-071, A49861-072, A49861-073, A49861-074, A49930-011, A49930-012, A49930-013, A49930-014, A49930-015, A49930-016, A49930-017, A49930-018, A49930-019, A49930-020, A49930-021, A50118-011, A50118-012, A50118-013, A50118-014, A50118-015, A50118-016, A50118-017, A50118-018, A50118-019, A50118-020, A50118-021, A50118-022, A50118-023, A50118-024, A50118-025, A50281-011, A50281-012, A50281-013, A50281-014, A50281-015, A50281-016, A50281-017, A50281-018, A50281-019, A50281-020, A50281-021, A50281-022, A50281-023, A50281-024, A50281-025, A50329-011, A50329-012, A50329-013, A50329-014, A50329-015, A50360-011, A50360-012, A50360-013, A50360-014, A50360-015, A50360-018, A50360-020, A50360-021, A50360-022, A50360-023, A50360-024, A51087-019, A51087-020, A51087-021, A51087-022, A51087-023, A51087-024, A51087-025, A51087-026, A51087-027, A51087-028, A51087-029, A51087-030, A51087-031, A51087-032, A51723-011, A51723-012, A51723-013, A51723-014, A51723-015, A51723-016, A51723-017, A51723-018, A51723-019, A51723-020, A51723-021, A51723-022, A51723-023, A51723-024, A51723-025, A51978-026, A51978-027, A51978-028, A51978-029, A51978-030, A51978-031, A51978-032, A51978-033, A51978-034, A51978-035, A51978-036, A51978-037, A51992-011, A51992-012, A51992-013, A51992-014, A51992-015, A51992-016, A51992-017, A51992-018, A51992-019, A51992-020, A51992-021, A51992-022, A51992-023, A51992-024, A51992-025, A52104-056, A52104-057, A52104-058, A52104-059, A52104-060, A52104-061, A52104-062, A52104-063, A52174-011, A52174-012, A52174-013, A52174-015, A52283-052, A52283-053, A52283-054, A52283-055, A52283-056, A52283-057, A52283-058, A52283-059, A52283-060, A52283-061, A52283-062, A52283-063, A52283-064, A52283-065, A52283-066, A52510-011, A52510-012, A52510-013, A52510-014, A52510-015, A52510-016, A52510-017, A52510-018, A52510-019, A52510-020, A52510-021, A52510-022, A52510-023, A52510-024, A52510-025, A52981-041, A52981-042, A52981-043, A52981-044, A52981-045, A52981-046, A52981-047, A52981-048, A52981-050, A52981-051, A52981-052, A52981-053, A52981-054, A52981-055, A52981-056, A52981-057, A52981-058, A52981-059, A52981-060, A52981-061, A52981-062, A52981-063, A52981-064, A52981-065, A52981-066, A52981-067, A53050-021, A53050-022, A53050-023, A53050-024, A53050-025, A53050-026, A53050-027, A53050-028, A53050-029, A53050-030, A53050-031, A53050-032, A53082-011, A53082-012, A53082-013, A53082-014, A53082-015, A53082-016, A53082-017, A53082-018, A53082-019, A53082-020, A53082-021, A53082-022, A53082-023, A53082-024, A53082-025, A53133-179, A53133-180, A53133-181, A53133-182, A53133-183, A53133-184, A53133-185, A53133-186, A53133-187, A53133-188, A53133-189, A53133-190, A53133-191, A53133-192, A53148-016, A53148-017, A53148-018, A53148-019, A53148-020, A53148-021, A53148-022, A53148-023, A53148-024, A53148-025, A53148-026, A53148-027, A53148-028, A53148-029, A53181-044, A53181-045, A53181-046, A53181-047, A53181-048, A53181-049, A53181-050, A53181-051, A53181-052, A53181-053, A53181-054, A53181-055, A53181-056, A53181-057, A53181-058, A53181-059, A53284-047, A53284-048, A53284-049, A53284-050, A53284-051, A53284-052, A53284-053, A53284-054, A53284-055, A53284-056, A53284-057, A53284-058, A53284-059, A53349-084, A53349-085, A53349-086, A53349-087, A53349-088, A53349-089, A53349-090, A53349-091, A53349-092, A53349-093, A53770-024, A53770-025, A53770-026, A53770-027, A53770-028, A53770-029, A53770-030, A53813-051, A53813-052, A53813-053, A53813-054, A53813-055, A53813-056, A53813-057, A53813-058, A53813-059, A53813-060, A53813-061, A53813-062, A53813-063, A53813-064, A54163-028, A54163-029, A54293-021, A54293-022, A54293-023, A54399-031, A54399-032, A54399-033, A54399-034, A54399-035, A54399-036, A54399-037, A54399-038, A54399-039, A54399-040, A54399-041, A54399-042, A54654-011, A54654-012, A54654-013, A54654-014, A54654-015, A54654-016, A54654-017, A54654-018, A54654-019, A54654-020, A54654-021, A54654-022, A54654-023, A54654-024, A54654-025, A54654-026, A54779-011, A54779-012, A54779-013, A54779-014, A54779-015, A54779-016, A54779-017, A54779-018, A54779-019, A54779-020, A54779-021, A54779-022, A54779-023, A54783-013, A54783-014, A54783-015, A54783-016, A54783-017, A54783-018, A54783-019, A54783-020, A54783-022, A54783-025, A54809-011, A54809-012, A54809-013, A54809-014, A54809-015, A54809-016, A54809-017, A54809-018, A54809-019, A54809-020, A54809-021, A54809-022, A54809-023, A54809-024, A54809-025, A54847-011, A54847-012, A54847-013, A54960-040, A54960-041, A54960-042, A54960-043, A54960-044, A54960-045, A54960-046, A54960-047, A54960-048, A54960-049, A54960-050, A54960-051, A54960-052, A54960-053, A55095-090, A55095-091, A55095-092, A55095-093, A55095-094, A55095-095, A55095-096, A55095-097, A55095-098, A55255-011, A55255-012, A55255-013, A55255-014, A55255-015, A55255-016, A55255-017, A55255-018, A55255-019, A55255-020, A55255-021, A55255-022, A55255-023, A55255-024, A55255-025, A55255-026, A55255-027, A55255-028, A55581-022, A55581-023, A55581-024, A55610-011, A55610-012, A55610-013, A55610-014, A55610-015, A55610-016, A55610-017, A55610-018, A55610-019, A55610-020, A55610-021, A55610-022, A55610-023, A55610-024; e) DBM T42100AUS 2.5CMX10CM FLEX GRAFTON, REF T42100AUS, GTIN 00643169430969, Serial Numbers: A43708-045, A43708-046, A43708-047, A43708-048, A43995-011, A43995-012, A43995-013, A43995-014, A43995-015, A43995-016, A43995-017, A43995-018, A43995-019, A43995-020, A43995-021, A43995-022, A43995-023, A43995-024, A43995-025, A43995-026, A43995-027, A43995-028, A43995-029, A43995-030, A43995-031, A43995-032, A43995-033, A43995-034, A43995-035, A43995-036, A43995-037, A43995-038, A43995-039, A43995-040, A43995-041, A44446-066, A44446-067, A44446-068, A44446-069, A44446-070, A44446-071, A44446-072, A44446-073, A44446-074, A44446-075, A44446-076, A44446-077, A44446-078, A44446-079, A44446-080, A44446-081, A44446-082, A44446-083, A44446-084, A44446-085, A44446-086, A44446-087, A44446-088, A44446-089, A44446-090, A44446-091, A44446-092, A44446-093, A44616-036, A44616-037, A44616-038, A44616-039, A44616-040, A44616-041, A44616-042, A44616-043, A44616-044, A44616-045, A44616-046, A44616-047, A45898-027, A45898-028, A45898-029, A45898-030, A45898-031, A45898-032, A45898-033, A45898-034, A45898-035, A45898-036, A45898-037, A45898-038, A45898-039, A45898-040, A46583-022, A46583-023, A46583-024, A46583-025, A46583-026, A46583-027, A46583-028, A46583-029, A46583-030, A46583-031, A46583-032, A46583-033, A46583-034, A46583-035, A46583-036, A46583-037, A46583-038, A46583-039, A46583-040, A46583-041, A47048-011, A47048-012, A47048-013, A47048-014, A47048-015, A47048-016, A47048-017, A47048-018, A47048-019, A47048-020, A47048-021, A47048-022, A47048-023, A47048-024, A47048-025, A47345-039, A47514-032, A47514-033, A47514-034, A47514-035, A47514-036, A47514-037, A47514-038, A48154-022, A48154-023, A48154-024, A48154-025, A48154-026, A50504-045, A50504-046, A50504-047, A50504-048, A50504-049, A50504-050, A50504-051, A50705-056, A50705-057, A50705-058, A50705-059, A50705-060, A50705-061, A50705-062, A50705-063, A50705-064, A50705-065, A50705-066, A50705-067, A50705-068, A50705-069, A50705-070, A50705-071, A50705-072, A50705-073, A50705-074, A50705-075, A50705-076, A50705-077, A50705-078, A50705-079, A50705-080, A50705-081, A50705-082, A50705-083, A50705-084, A52987-011, A52987-012, A52987-013, A52987-014, A52987-015, A52987-016, A52987-017, A52987-018, A52987-019, A52987-020, A52987-021, A52987-022, A52987-023, A52987-024; f) DBM T42100INT 2.5CMX10CM FLEX GRAFTON, REF T42100INT, GTIN 00643169964884, Serial Numbers: A41864-022, A41864-025, A43220-014, A43220-015, A43220-016, A43220-017, A43220-018, A43220-019, A43220-020, A43220-021, A43220-022, A43220-023, A43220-024, A43220-025, A43220-026, A43220-027, A46552-025, A46991-046, A47264-042, A49099-011, A49099-012, A49099-013, A49099-014, A49099-015, A51978-025.A52104-064, A52104-065, A52104-066, A52981-070, A53349-081, A53349-082, A53349-083, A54391-044, A55429-033, A55429-034, A55429-035, A55429-036, A55429-037, A55429-038, A55429-039, A55429-040, A55429-041, A55429-042; g) DBM T42110 2.5CMX5CM FLEXGRAFTON, REF T42110, GTIN 00643169123014, Serial Numbers: A40174-080, A40174-081, A40174-082, A40174-083, A40174-084, A40174-085, A40174-086, A40174-087, A40174-088, A40174-089, A40174-090, A40174-091, A40174-092, A40174-093, A40174-094, A40174-095, A40174-096, A40174-097, A40174-098, A40174-099, A40174-100, A40174-101, A40174-102, A40174-103, A41995-094, A41995-095, A41995-096, A41995-097, A41995-098, A41995-099, A41995-100, A41995-101, A41995-102, A41995-103, A41995-104, A41995-105, A41995-106, A41995-107, A41995-108, A41995-109, A41995-110, A41995-111, A41995-112, A41995-113, A41995-114, A41995-115, A41995-116, A41995-117, A42328-024, A42328-025, A42328-026, A42328-027, A42328-028, A42328-029, A42328-030, A42328-031, A42328-032, A42328-033, A42328-034, A42328-035, A42328-036, A42328-037, A42328-038, A42328-039, A42328-040, A42328-042, A42328-043, A42328-044, A42328-045, A42328-046, A42328-047, A42328-048, A42328-049, A42328-050, A42328-051, A42594-038, A42594-039, A42594-040, A42594-041, A42594-042, A42594-043, A42594-044, A42594-045, A42594-046, A42594-047, A42594-048, A42594-049, A42594-050, A42594-051, A42594-052, A42594-053, A42594-054, A42594-055, A42594-056, A42594-057, A42594-058, A42594-059, A42594-060, A42594-061, A42594-062, A42594-063, A42594-064, A42851-053, A42851-054, A42851-055, A42851-056, A42851-057, A42851-059, A42851-060, A42851-061, A42851-062, A42851-064, A42851-065, A42851-066, A42851-067, A42851-068, A42851-069, A43100-051, A43100-052, A43100-053, A43100-054, A43100-055, A43100-056, A43100-057, A43100-058, A43100-059, A43100-060, A43100-061, A43100-062, A43100-063, A43100-064, A43100-065, A43100-066, A43100-067, A43100-068, A43100-069, A43100-070, A43100-071, A43100-072, A43100-073, A43100-074, A43100-075, A43100-076, A43100-077, A43100-078, A43100-079, A43100-080, A43155-027, A43155-028, A43155-029, A43155-030, A43155-031, A43155-032, A43155-033, A43155-034, A43155-035, A43947-031, A43947-032, A43947-033, A43947-034, A43947-035, A43947-036, A43947-037, A43947-038, A43947-039, A43947-040, A43947-041, A43947-042, A43947-043, A43947-044, A43947-045, A43947-046, A43947-047, A43947-048, A43947-049, A43947-050, A43947-051, A43947-052, A43947-053, A43947-054, A43947-055, A44398-036, A44398-037, A44398-038, A44398-039, A44398-040, A44398-041, A44398-042, A44398-043, A44398-044, A44398-045, A44398-046, A44398-047, A44398-048, A44398-049, A44398-050, A44398-051, A44398-052, A44398-053, A44398-054, A44398-055, A44398-056, A44398-057, A44398-058, A44574-018, A44574-020, A44574-021, A44574-022, A44574-023, A44574-024, A44574-025, A44574-026, A44574-027, A44574-028, A44574-029, A44574-030, A44574-031, A44574-032, A44574-033, A44574-034, A44574-035, A44574-036, A44574-037, A44574-038, A44574-039, A44574-040, A44574-041, A44574-043, A44574-044, A45275-036, A45275-037, A45275-038, A45275-039, A45275-040, A45275-041, A45275-042, A45275-043, A45275-044, A45275-045, A45275-046, A45275-047, A45275-048, A45275-049, A45275-050, A45275-051, A45275-052, A45275-053, A45275-054, A45275-055, A45275-056, A45275-057, A45275-058, A45275-059, A45502-011, A45502-012, A45502-013, A45502-014, A45502-015, A45502-016, A45502-017, A45502-018, A45502-019, A45502-020, A45502-021, A45502-022, A45502-023, A45502-024, A45502-025, A45502-026, A45502-027, A45502-028, A45502-029, A45502-030, A45502-031, A45502-032, A45502-033, A45502-034, A45502-035, A45502-036, A45502-037, A45502-038, A45502-039, A45502-040, A45752-011, A45752-012, A45752-013, A45752-014, A45752-015, A45752-016, A45752-017, A45752-018, A45752-019, A45752-020, A45752-021, A45752-022, A45752-023, A45752-024, A45752-025, A45752-026, A45752-027, A45752-028, A45752-029, A45752-030, A45752-031, A45752-032, A45752-033, A45752-034, A45752-035, A45752-036, A45752-037, A45752-038, A45752-039, A45772-016, A45772-017, A45772-018, A45772-019, A45772-020, A45772-021, A45772-022, A45772-023, A45772-024, A45772-025, A45772-026, A45772-027, A45772-028, A45772-029, A45772-030, A45772-031, A45772-032, A45772-033, A45772-034, A45772-035, A45772-036, A45772-040, A45772-041, A45772-042, A45772-043, A45772-044, A45826-015, A45826-016, A45826-017, A45826-019, A45826-020, A45826-021, A45826-022, A45826-023, A45826-024, A45826-026, A45826-027, A45826-028, A45826-029, A45826-030, A45826-031, A45826-032, A45826-033, A45826-034, A45826-035, A45826-036, A45826-037, A45826-038, A45826-039, A45826-040, A45826-041, A45826-042, A45826-043, A46078-015, A46078-016, A46078-017, A46078-018, A46078-019, A46078-020, A46078-021, A46078-022, A46078-023, A46078-024, A46078-025, A46078-026, A46078-027, A46078-028, A46078-029, A46078-030, A46078-031, A46078-032, A46078-033, A46078-035, A46711-060, A46711-061, A46711-062, A46711-063, A46711-064, A46711-065, A46711-066, A46711-067, A46711-068, A46711-069, A46711-070, A46711-071, A46711-072, A46711-073, A46711-074, A46711-075, A46717-031, A46717-032, A46717-033, A46717-034, A46717-035, A46717-036, A46717-037, A46717-038, A46717-039, A46717-040, A46841-031, A46841-032, A46841-033, A46841-034, A46841-035, A46841-036, A46841-037, A46841-038, A46841-039, A46841-040, A46841-041, A46841-042, A46841-043, A46841-044, A46841-045, A46841-046, A46841-047, A46841-048, A46841-049, A46841-050, A47233-026, A47233-027, A47233-028, A47233-029, A47233-030, A47233-031, A47233-032, A47233-033, A47233-034, A47233-035, A47233-036, A47233-038, A47233-039, A47233-041, A47233-042, A47233-043, A47585-011, A47585-012, A47585-013, A47585-014, A47585-015, A47585-016, A47585-017, A47585-018, A47585-019, A47585-020, A47585-021, A47585-022, A47585-023, A47585-024, A47585-025, A47585-026, A47585-027, A47585-028, A47585-029, A47585-030, A47585-031, A47585-032, A47585-033, A47585-034, A47585-035, A47585-036, A47832-028, A47832-029, A47832-030, A48202-011, A48202-012, A48202-013, A48202-014, A48202-015, A48202-016, A48202-017, A48202-018, A48202-019, A48202-021, A48202-022, A48202-023, A48202-024, A48202-025, A48202-026, A48202-027, A48202-028, A48202-029, A48202-030, A48202-031, A48202-032, A48202-033, A48202-034, A48202-035, A48202-036, A48202-037, A48202-038, A48202-039, A48202-040, A48202-041, A48202-042, A48243-016, A48243-017, A48243-018, A48243-019, A48243-020, A48243-021, A48243-022, A48243-023, A48243-024, A48243-025, A48243-026, A48243-027, A48243-028, A48243-029, A48243-030, A48243-031, A48243-032, A48243-033, A48243-034, A48243-035, A48243-036, A48243-037, A48243-038, A48243-039, A48243-040, A48243-041, A48312-024, A48312-025, A48312-026, A48312-027, A48433-011, A48433-012, A48433-013, A48433-014, A48433-015, A48433-016, A48433-017, A48433-018, A48433-019, A48433-020, A48433-021, A48433-022, A48433-023, A48433-024, A48433-025, A48433-026, A48433-027, A48433-028, A48433-029, A48433-030, A48433-031, A48433-032, A48433-033, A48433-034, A48433-035, A48433-036, A48556-022, A48556-023, A48556-024, A48556-025, A48556-026, A48556-027, A48556-028, A48556-029, A48730-031, A48730-032, A48730-033, A48730-034, A48730-035, A48730-036, A48730-037, A48730-038, A48730-039, A48730-040, A48730-041, A48730-042, A48730-043, A48730-044, A48730-045, A48730-046, A48730-047, A48730-048, A48730-049, A48730-051, A48730-052, A48730-053, A48730-054, A48730-055, A48730-056, A48730-057, A48730-058, A48730-059, A48730-060, A48730-061, A49927-026, A49927-027, A49927-028, A49927-029, A49927-030, A49927-031, A49927-032, A49927-033, A49927-034, A49927-035, A49927-036, A49927-037, A49927-038, A49927-039, A49927-040, A49927-041, A49927-042, A50183-036, A50183-037, A50183-038, A50183-039, A50183-040, A50183-041, A50183-042, A50183-043, A50183-044, A50183-045, A50183-046, A50183-047, A50183-048, A50183-049, A50183-050, A50183-051, A50183-052, A50183-053, A51102-011, A51102-012, A51102-013, A51102-014, A51102-015, A51102-016, A51102-017, A51102-018, A51102-019, A51102-020, A51102-021, A51102-022, A51102-023, A51102-024, A51102-025, A51102-026, A51102-027, A51102-028, A51102-029, A51102-030, A51102-031, A51102-032, A51102-033, A51102-034, A51102-035, A51102-036, A51102-037, A51102-038, A51410-011, A51410-012, A51410-013, A51410-014, A51410-015, A51410-016, A51410-017, A51410-018, A51410-019, A51410-020, A51410-021, A51410-022, A51410-023, A51410-024, A51410-025, A51410-026, A51410-027, A51410-028, A51410-029, A51410-030, A51410-031, A51410-032, A51410-033, A51410-034, A51410-035, A51410-036, A51410-037, A51410-038, A51410-039, A51410-040, A52882-012, A52882-013, A52882-014, A52882-015, A52882-016, A52882-017, A52882-018, A52882-019, A52882-020, A52882-021, A52882-022, A52882-023, A52882-024, A52882-025, A52882-026, A52882-027, A52882-028, A52882-029, A52882-030, A52882-031, A52882-032, A52882-033, A52882-034, A52882-035, A52882-036, A52882-037, A52882-038, A52882-039, A52882-040, A54293-024, A54293-025, A54293-026, A54293-027, A54293-028, A54293-029, A54293-030, A54293-031, A54293-032, A54293-033, A54293-034, A54293-035, A54293-036, A54293-037, A54293-038, A54293-039, A54293-040, A54293-041, A54293-042, A54293-043, A54293-044, A54293-045, A54311-021, A54311-022, A54311-023, A54311-024, A54311-025, A54311-026, A54311-027, A54311-028, A54311-029, A54311-030, A54311-031, A54311-032, A54311-033, A54311-034, A54311-035, A54311-036, A54311-037, A54311-038, A54311-039, A54311-040, A54311-041, A54311-042, A54311-043, A54391-021, A54391-022, A54391-023, A54391-024, A54391-025, A54391-026, A54391-027, A54391-028, A54391-029, A54391-030, A54391-031, A54391-032, A54391-033, A54391-034, A54391-035, A54391-036, A54391-037, A54391-038, A54391-039, A54391-040, A54391-041, A54391-042, A54391-043, A54541-024, A54541-025, A54541-026, A54541-027, A54541-028, A54541-029, A54541-030, A54541-031, A54541-032, A54541-033, A54541-034, A54541-035, A54541-036, A54541-037, A54541-038, A54541-039, A54541-040, A54847-014, A54847-015, A54847-016, A54847-017, A54847-018, A54847-019, A54847-020, A54847-021, A54847-022, A54847-023, A54847-024, A54847-025, A54847-026, A54847-027, A54847-028, A54847-029, A54847-030, A54847-031, A54847-032, A54847-033, A54847-034, A54847-035, A54847-036, A55654-011, A55654-012, A55654-013, A55654-014, A55654-015, A55654-016, A55654-017, A55654-018, A55654-019, A55654-020, A55654-021, A55654-022, A55654-023, A55654-024, A55654-025, A55654-026, A55654-027, A55654-029, A55654-030; h) DBM T42110AUS 2.5CMX5CM FLEX GRAFTON, REF T42110AUS, GTIN 00643169430952, Serial Numbers: A41995-087, A45415-046, A45415-049; i) DBM T42110INT 2.5CMX5CM FLEXGRAFTON, REF T42110INT, GTIN 00643169964891, Serial Numbers: A42232-064, A42232-065, A42232-066, A42232-067, A42232-068, A42232-069, A42232-070, A42232-071, A42232-072, A42232-073, A42232-074, A42232-075, A42232-076, A42232-077, A42232-078, A42232-079, A42232-080, A42232-081, A42232-082, A42232-083, A42232-084, A42232-085, A42232-086, A42232-087, A42232-088, A42232-089, A42796-022, A42796-023, A42796-024, A42796-025, A42796-026, A42796-027, A42796-028, A42796-029, A42796-030, A42796-031, A42796-032, A42796-033, A42796-034, A42796-035, A42796-036, A42796-037, A42796-039, A42851-070, A42851-071, A42851-072, A42851-073, A42851-074, A42851-075, A42851-076, A42984-031, A42984-032, A44704-039, A44704-040, A44704-041, A44704-042, A44704-043, A44704-044, A44704-045, A46841-051, A46841-052, A46841-053, A46841-054, A46841-055, A47585-037, A47585-038, A47585-039, A47585-040, A47585-041, A47864-011, A47864-012, A47864-013, A47864-014, A47864-015, A47864-016, A48433-037, A48433-038, A48433-039, A48433-040, A48433-041, A48547-045, A48547-046, A48547-047, A48547-048, A48547-049, A48547-050, A48547-051, A48547-052, A48547-053, A49927-048, A49927-049, A50183-055, A50183-056, A50183-057, A50183-059, A50183-060, A50183-061, A50183-062, A52924-011, A52924-012, A52924-013, A52924-014, A52924-015, A52924-016, A52924-017, A52924-018, A52924-020, A52924-021, A52924-022, A52924-023, A52924-026, A52924-027, A52924-028, A52924-029, A52924-030, A53118-169, A53118-170, A53118-171, A53118-172, A53118-173, A53118-174, A53118-175, A54541-011, A54541-012, A54541-013, A54541-014, A54541-015, A54541-016, A54541-017, A54541-018, A54541-019, A54541-020, A54541-021; j) DBM T42150INT 5CM X 5CM FLEX GRAFTON, REF T42150INT, GTIN 00643169964907, Serial Numbers: A42796-040, A42796-041, A42796-043, A42796-044, A46841-056, A46841-057, A52924-031, A52924-032, A52924-033, A52924-034, A55301-011, A55301-012, A55301-013, A55301-014, A55301-015, A55301-016, A55301-017, A55301-018, A55301-019, A55301-020, A55301-022.

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

24 devices cleared under K051195 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 91697).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page