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RecallWatchMedical Device Safety
Class IIOngoingZ-0769-2025

Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK MP Reconstruction System Neck Segment (with suture holes

Waldemar Link GmbH & Co. KG (Mfg Site)Norderstedt, GermanyReported Jan 1, 2025 · 1 year ago
Legal News Analyst ·

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).

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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 femurUDI-DI
    UDI-DI 04026575409785
    59 affected lots
    170418/1971231113/2472240219/0512240311/0727170515/1335231113/2473240219/0513240311/0729
    +51 more170717/1773231113/2474240219/0514240311/0730180219/1681231113/2475240219/0515240311/0731180219/1687231113/2476240219/0516240311/0732211122/0489231113/2478240219/0518240311/0733231113/2462231113/2479240219/0519240311/0734231113/2463240219/0505240219/0520240311/0735231113/2464240219/0506240219/0521240311/0736231113/2465240219/0507240219/0522240311/0737231113/2466240219/0508240219/0523240311/0738231113/2467240219/0509240219/0524240311/0739231113/2468240219/0510240219/0525240311/0740231113/2469240219/0511240219/0526240311/0741231113/2470240311/0742240311/0726

What the firm 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 complaints@linkbio.com for any questions.

DistributionShow details

US Nationwide distribution in the states of AL, FL.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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