PASS LP recallZ-2458-2023 · Medicrea International · initiated Jul 12, 2023
Open, Classified
Is my device affected?
- 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.
- If yours is listed, follow the instructions from Medicrea International or your healthcare provider. The company's action is summarized under what the company is doing.
- 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
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
FDA root cause category: Under Investigation by firm
What the company is doing
Beginning 12 July 2023, In the U.S. Medtronic disseminated an URGENT: MEDICAL PRODUCT RECALL to its consignees via UPS 2-Day delivery. The notice explained the problem, risk, and requested the following: Medtronic requests that you immediately take the following actions: Identify and quarantine any unused impacted product(s). Return all unused and non-expired product(s) in your inventory to Medtronic following the instructions in the enclosed Customer Confirmation Form. Your Medtronic Sales Representative can assist in returning any affected consignment and loaner inventory, if applicable. Complete the Customer Confirmation Form enclosed with this letter (even if you have no product to return), acknowledging that you have received this information. This notice should be distributed to all others in your organization who should be aware, or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records.
Recall details
- Recall number
- Z-2458-2023
- Status
- Open, Classified
- Initiated by the company
- Jul 12, 2023
- Posted by the FDA
- Aug 24, 2023
- Recalling firm
- Medicrea International
- Quantity
- 963 units
- Product code
- MNI
- FDA submissions
- K110497
- Distribution
- US nationwide
Product description
PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, g) B02316545Z, h) B02316550Z, i) B02317540Z, j) B02317545Z, k) B02317550Z; intervertebral fusion device - cervical
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
a) B02315535Z, GTIN 03613720185086, Lot Numbers: 21J0184; b) B02315540Z, GTIN 03613720185116, Lot Numbers: 18E0322, 18F1011, 18G0704, 18I0780, 18K0862, 19B0091, 19B0731, 19D0267, 19F0460, 19J0742, 20A0966, 20F0008, 20I0200, 20I0833, 22I0616; c) B02315545Z, GTIN 03613720185147, Lot Numbers: 18H0617, 18I0682, 18J0215, 18K0863, 19K0545, 20H0147; d) B02315550Z, GTIN 03613720185178, Lot Numbers: 19E0306, 20F0009; e) B02316535Z, GTIN 03613720185321, Lot Numbers: 21J0185, 21J0899; f) B02316540Z, GTIN 03613720185352, Lot Numbers: 18E0478, 18H0672, 18K0278, 18K0864, 19A0645, 19B0318, 19B0777, 19C0417, 19C0739, 19E0082, 19I0573, 20A0596, 20B0687, 20H0148, 20J0414, 21A0107, 22A0297, 22I0339; g) B02316545Z, GTIN 03613720185383, Lot Numbers: 18D1035, 18E0508, 18F0534, 18G0170, 18G0591, 18H0588, 18J0054, 18K0279, 18K0865, 19A0066, 19B0093, 19B0912, 19C0138, 19D0177, 19E0084, 19G0188, 19J0227, 19J0228, 19K0764, 19L0360, 19L0580, 20B0688, 20H0151, 20J0415, 20L0238, 21A0109, 21A0642, 21D0174, 21F0505, 21L0394, 22A0047, 22L0091; h) B02316550Z, GTIN 03613720185413, Lot Numbers: 21A0506, 21C0501; i) B02317540Z, GTIN 03613720185598, Lot Numbers: 21A0110, 21A0508, 21A0524, 22B0782; j) B02317545Z, GTIN 03613720185628, Lot Numbers: 20E0097, 21A0076, 21B0498; k) B02317550Z, GTIN 03613720185659, Lot Numbers: 20C0294, 20H0508, 20J0283, 22B0366
Devices named in this recall
11 devices in the FDA device registry whose identifier appears in the recall's code information.
- PASS LP B02316545ZMedicrea International · Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall3 reports
- PASS LP B02315535ZMedicrea International · Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall0 reports
- PASS LP B02315540ZMedicrea International · Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall0 reports
- PASS LP B02315545ZMedicrea International · Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall0 reports
- PASS LP B02315550ZMedicrea International · Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall0 reports
- PASS LP B02316535ZMedicrea International · Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall0 reports
- PASS LP B02316540ZMedicrea International · Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall0 reports
- PASS LP B02316550ZMedicrea International · Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall0 reports
- PASS LP B02317540ZMedicrea International · Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall0 reports
- PASS LP B02317545ZMedicrea International · Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall0 reports
- PASS LP B02317550ZMedicrea International · Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 92738).
- Z-2452-2023 · Open, ClassifiedIMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242C12062810, g) B242C12122810, h) B242C12123310, i)…
- Z-2453-2023 · Open, ClassifiedIMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar
- Z-2455-2023 · Open, ClassifiedIMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g) B16124513, h) B16164009, i) B16164013, j) B16165009, k)…
- Z-2456-2023 · Open, ClassifiedIMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773, h) B20181943, i) B20181953, j) B20181963, k)…
- Z-2457-2023 · Open, ClassifiedIMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206,…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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