—#207025

Product

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

FDA product code: OJH — Orthopedic Tray
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.

Timeline

Recall initiated: 2024-03-22
Posted by FDA: 2024-08-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #207025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.