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Medline medical procedure kits labeled as follows recallZ-2714-2024 · MEDLINE INDUSTRIES, LP - Northfield · initiated Mar 22, 2024

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 MEDLINE INDUSTRIES, LP - Northfield 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

A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.

FDA root cause category: Under Investigation by firm

What the company is doing

Medline Industries issued a Safety Alert to its consignees on 03/22/2024 via email and certified mail. The notice explained the problem with the device and requested that consignees follow the instructions for use. Distributors or those who further transferred the affected product were directed to notify their consignees.

Recall details

Recall number
Z-2714-2024
Status
Open, Classified
Initiated by the company
Mar 22, 2024
Posted by the FDA
Aug 22, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
14977 units
Product code
OJH
Distribution
Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.

Product description

Medline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYNJ909699; b) BACK CDS, REF CDS984000C; c) EXTREMITY, REF DYNJ900847A; d) HAND-LF, REF DYNJ902619G; e) HIP PINNING CDS, REF CDS984009C; f) HIP PINNING/TFN/ANTERIOR HIP, REF DYNJ902380K; g) KNEE, REF DYNJ904771B; h) KNEE ARTHROSCOPY, REF DYNJ905519D; i) KNEE ARTHROSCOPY, REF DYNJ906273F; j) KNEE ARTHROSCOPY, REF DYNJ909747; k) KNEE ARTHROSCOPY V, REF DYNJS2029D; l) LAMINECTOMY, REF DYNJ907159A; m) LOWER EXTREMITY, REF DYNJ904767A; n) LOWER EXTREMITY, REF DYNJ905518F; o) LOWER EXTREMITY, REF DYNJ909938; p) MINOR EXTREMITY, REF DYNJ909939; q) PODIATRY, REF DYNJ906275D; r) SHOULDER, REF DYNJ904769C; s) SHOULDER, REF DYNJ905511D; t) SHOULDER, REF DYNJ909749; u) SHOULDER ARTHROSCOPY, REF DYNJ906274F; v) SHOULDER ARTHROSCOPY CDS, REF CDS984008C; w) SOUTH EXTREMITY, REF DYNJ909212A; x) SPINE, REF DYNJ905512F; y) TOTAL, REF DYNJ909704; z) TOTAL HIP, REF DYNJ907157A; aa) TOTAL HIP BASIC, REF DYNJ902368K; bb) TOTAL JOINT, REF DYNJ905513G; cc) TOTAL JOINT, REF DYNJ908375C; dd) TOTAL JOINT II, REF DYNJS2027F; ee) TOTAL KNEE, REF DYNJ907158A; ff) TOTAL KNEE CDS, REF CDS983991C; gg) TOTAL SHOULDER, REF DYNJ902367J; hh) TURK-HAND, REF DYNJ905852C; ii) UPPER EXTREMITY, REF DYNJ905514D

Code information (models, lots, serial numbers)

Show the full code information (5k characters)

a) REF DYNJ909699, UDI/DI 40195327446759 (case), 10195327446758 (unit), Lot Numbers: DYNJ909699, DYNJ909699, DYNJ909699, DYNJ909699, DYNJ909699, DYNJ909699; b) REF CDS984000C, UDI/DI 40889942011552 (case), 10889942011551 (unit), Lot Numbers: 22GBT604, 22IBI040, 23ABA955, 23DBT170, 23EBU747, 23HBB409; c) REF DYNJ900847A, UDI/DI 40888277771209 (case), 10888277771208 (unit), Lot Numbers: d) REF DYNJ902619G, UDI/DI 40195327214488 (case), 10195327214487 (unit), Lot Numbers: 22FBG650, 22FBK152, 22FBW287, 22HBA416, 22HBG372, 22HBS529, 22JBA184, 23EBC466, 23HBL953; e) REF CDS984009C, UDI/DI 40888277768971 (case), 10888277768970 (unit), Lot Numbers: 22FBL426, 22GBU282, 23CBD236, 23HBY917; f) REF DYNJ902380K, UDI/DI 40195327507009 (case), 10195327507008 (unit), Lot Numbers: 23KBX257; g) REF DYNJ904771B, UDI/DI 40195327137190 (case), 10195327137199 (unit), Lot Numbers: 22EMB001, 22IMF542, 22KMC063, 23AME421, 23CMC716, 23DME033, 23FMI125, 23HMC273, 23HMI602, 23LME735; h) REF DYNJ905519D, UDI/DI 40193489967396 (case), 10193489967395 (unit), Lot Numbers: 22GMG221, 22HMB217, 22LMJ233, 23AME962, 23AMI318, 23AMJ640, 23DMI673, 23IMG465, 23LMD163; i) REF DYNJ906273F, UDI/DI 40195327511013 (case), 10195327511012 (unit), Lot Numbers: 23JBH985; j) REF DYNJ909747, UDI/DI 40195327468201 (case), 10195327468200 (unit), Lot Numbers: 23HBZ535, 23KBF559; k) REF DYNJS2029D, UDI/DI 40193489214414 (case), 10193489214413 (unit), Lot Numbers: 22IDA884, 22LDA526, 23CDA885, 23FDA459, 23JDB741; l) REF DYNJ907159A, UDI/DI 40193489970419 (case), 10193489970418 (unit), Lot Numbers: 22EME489, 22FMH850, 22IMA282, 22JME894, 22LME340, 23AMB899, 23AMB937, 23AMF082, 23AMG074, 23AMJ063, 23BMF089, 23CMA038, 23FMF222, 23GMB990, 23GMF747, 23HMH495, 23JMC384, 23LMD528; m) REF DYNJ904767A, UDI/DI 40889942850953 (case), 10889942850952 (unit), Lot Numbers: 22EMI503, 22IMC879, 22KMD093, 22LME746, 23AMC120, 23DMA417, 23DMD168, 23FME590, 23GMH321, 23HMG168; n) REF DYNJ905518F, UDI/DI 40195327040407 (case), 10195327040406 (unit), Lot Numbers: 22FMI412, 22HMD694, 22IMA909, 22JMC316, 22KMC860, 22LMD325, 23AMF318, 23BMG871, 23EMF948, 23FMA357, 23GMD311, 23HMG163, 23JMA417, 23KMB755, 23LME256; o) REF DYNJ909938, UDI/DI 40195327511228 (case), 10195327511227 (unit), Lot Numbers: 23JBI008; p) REF DYNJ909939, UDI/DI 40195327511235 (case), 10195327511234 (unit), Lot Numbers: 23JBH778, 23KBU569; q) REF DYNJ906275D, UDI/DI 40195327510986 (case), 10195327510985 (unit), Lot Numbers: 23JBI291, 23LBO829; r) REF DYNJ904769C, UDI/DI 40195327137039 (case), 10195327137038 (unit), Lot Numbers: 22FMB469, 22IMA132, 22KMD488, 22LME616, 23GMF950, 23HME593, 23JMG901, 23KMG320; s) REF DYNJ905511D, UDI/DI 40193489967549 (case), 10193489967548 (unit), Lot Numbers: DYNJ905511D, DYNJ905511D, DYNJ905511D, DYNJ905511D, DYNJ905511D, DYNJ905511D, DYNJ905511D; t) REF DYNJ909749, UDI/DI 40195327468225 (case), 10195327468224 (unit), Lot Numbers: 23IBM342; u) REF DYNJ906274F, UDI/DI 40195327511020 (case), 10195327511029 (unit), Lot Numbers: 23JBQ500, 23LBI456; v) REF CDS984008C, UDI/DI 40888277768988 (case), 10888277768987 (unit), Lot Numbers: 22GBL020, 22JBE903, 23ABI396, 23ABM540, 23CBO804; w) REF DYNJ909212A, UDI/DI 40195327493241 (case), 10195327493240 (unit), Lot Numbers: 23JBA160, 23KBA970; x) REF DYNJ905512F, UDI/DI 40195327225378 (case), 10195327225377 (unit), Lot Numbers: 22JME529, 22KMD611, 22LMI893, 23BMI268, 23CMF328, 23FMG242, 23HMH500, 23IMC073, 23IMG464, 23JMI252, 23LMC546; y) REF DYNJ909704, UDI/DI 40195327446919 (case), 10195327446918 (unit), Lot Numbers: 23GBN059, 23KBA374; z) REF DYNJ907157A, UDI/DI 40193489970358 (case), 10193489970357 (unit), Lot Numbers: 22FMD804, 22JMG489, 22LMC517, 23BMA251, 23CMC137, 23CME146, 23DMA129, 23EMF952, 23FMG076, 23GMI555, 23IME182, 23JMI348, 23KMA447; aa) REF DYNJ902368K, UDI/DI 40195327505890 (case), 10195327505899 (unit), Lot Numbers: 23JBI661, 23KBT583; bb) REF DYNJ905513G, UDI/DI 40193489968027 (case), 10193489968026 (unit), Lot Numbers: 22FMG260, 22JMB517, 22JMF062, 23BME809, 23BMF391, 23BMG366, 23BMG367, 23BMI412, 23EMB428, 23FMA677, 23GMD648, 23JMC096, 23KMB846, 23LMC515; cc) REF DYNJ908375C, UDI/DI 40195327484263 (case), 10195327484262 (unit), Lot Numbers: 23IBL834, 23KBD095, 23LBB392; dd) REF DYNJS2027F, UDI/DI 40195327360314 (case), 10195327360313 (unit), Lot Numbers: 23EDA949, 23GDA203, 23HDB800, 23JDB140, 23KDA685, 23KDC088; ee) REF DYNJ907158A, UDI/DI 40183489970402 (case), 10195327137038 (unit), Lot Numbers: 22EME052, 22FMG234, 22IMC193, 22IMH124, 22LME781, 23CMD417, 23CME132, 23CMF812, 23DMF106, 23GMB888, 23HMH494, 23IME266, 23JMA733, 23KMH135; ff) REF CDS983991C, UDI/DI 40889942131410 (case), 10889942131419 (unit), Lot Numbers: 22FBB136, 22FBU282, 22GBN805, 22HBG300, 22HBS717, 22IBI043, 23CBT616, 23EBA215, 23EBU789, 23HBI490; gg) REF DYNJ902367J, UDI/DI 40195327505838 (case), 10195327505837 (unit), Lot Numbers: 23JBG975, 23KBN775, 23KBP709; hh) REF DYNJ905852C, UDI/DI 40195327214204 (case), 10195327214203 (unit), Lot Numbers: 22IBK464, 22IBM480, 23ABO113, 23ABO114, 23ABQ791, 23DBP733, 23EBR661, 23GBO389, 23HBX998, 23KBG164, 23LBF311; ii) REF DYNJ905514D, UDI/DI 40193489968034 (case), 10193489968033 (unit), Lot Numbers: 22EMA529, 22EMH888, 22FMB880, 22GME946, 22GMH574, 22GMI092, 22HMH887, 22LMD324, 22LMI453, 23AMG866, 23IMG780

Devices named in this recall

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

Other products in the same recall event

The FDA groups related products into one recall event (event 94356).

Sources and updates

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