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FDA (Device enforcement)Recalled 2024-12-05class ii

Waldemar Link GmbH & Co. KG (Mfg Site): LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Num

Hazard

Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).

Details from the source

Reason for recall: Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset). Distribution: US Nationwide distribution in the states of AL, FL. Quantity: 3 units Lot/code info: UDI-DI: 04026575409785 Serial Numbers: 170418/1971 231113/2472 240219/0512 240311/0727 170515/1335 231113/2473 240219/0513 240311/0729 170717/1773 231113/2474 240219/0514 240311/0730 180219/1681 231113/2475 240219/0515 240311/0731 180219/1687 231113/2476 240219/0516 240311/0732 211122/0489 231113/2478 240219/0518 240311/0733 231113/2462 231113/2479 240219/0519 240311/0734 231113/2463 240219/0505 240219/0520 240311/0735 231113/2464 240219/0506 240219/0521 240311/0736 231113/2465 240219/0507 240219/0522 240311/0737 231113/2466 240219/0508 240219/0523 240311/0738 231113/2467 240219/0509 240219/0524 240311/0739 231113/2468 240219/0510 240219/0525 240311/0740 231113/2469 240219/0511 240219/0526 240311/0741 231113/2470 240311/0742 240311/0726

UPC codes

04026575409785

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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