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MP Reconstruction Prosthesis recallZ-0769-2025 · Waldemar Link GmbH & Co. KG (Mfg Site) · initiated Dec 5, 2024

Class II Open, Classified All recalls posted in December 2024

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Waldemar Link GmbH & Co. KG (Mfg Site) or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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).

FDA root cause category: Under Investigation by firm

What the company is doing

Link Bio Corp. Dover, NJ issued Urgent Medical Device Recall to Consignees via email on December 5, 2024. Letter states reason for recall, health risk and action to take: Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return the affected product. Please return the product as soon as possible to the following address: LinkBio Corporation 69 King St Dover, NJ 07801 Please contact LinkBio at 973-625-1333 or [email protected] for any questions.

Recall details

Recall number
Z-0769-2025
Recall class
Class II
Status
Open, Classified
Initiated by the company
Dec 5, 2024
Posted by the FDA
Dec 26, 2024
Recalling firm
Waldemar Link GmbH & Co. KG (Mfg Site)
Quantity
3 units
Product code
LZO
FDA submissions
K142187
Distribution
US Nationwide distribution in the states of AL, FL.

Product 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.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

6 devices cleared under K142187 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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