Reported Jan 1, 2025 · Ongoing

LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm,…

Waldemar Link GmbH & Co. KG (Mfg Site)

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Waldemar Link GmbH & Co. KG (Mfg Site) · Oststr. 4-10 · Norderstedt · N/A

Is this the product you have?

  • 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 Number99-0984/32 Intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur
Lot codes and dates
  • UDI-DI04026575409785
  • 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
Amount recalled
3 units

Where it was sold

Why it was recalled

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).

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.