Class II Recall

Medline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYNJ909699; b) BACK CDS, REF CDS984000C; c

Summary

The FDA issued a Class II for Medline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYNJ90 by MEDLINE INDUSTRIES, LP - Northfield. Reason: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister..

Details

Source

Device Recall

External ID

Z-2714-2024

Action Date

2024-08-28

Status

Ongoing

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

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

Quantity Affected: 14977 units

Reason for Recall

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

Distribution

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

Type: Voluntary: Firm initiated

Recall Initiated: 2024-03-22

Company

MEDLINE INDUSTRIES, LP - Northfield

Northfield, IL

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 193 device recalls issued in the same week, part of 413 device-related FDA actions this month.

MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?

MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-2714-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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