🔍 RecallPedia

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 Number: 99-0984/32 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.

Class I - Dangerous
🏥 Medical Devices Recalled: December 5, 2024 Waldemar Link GmbH & Co. KG (Mfg Site) Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Waldemar Link GmbH & Co. KG (Mfg Site)
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).
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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 Number: 99-0984/32 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.

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0769-2025

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