Waldemar Link GmbH & Co. KG (Mfg Site): Device Recall

Recall Details

Recall Number

Z-0769-2025

Classification

Class II

Product Type

Device

Recalling Firm

Waldemar Link GmbH & Co. KG (Mfg Site)

Status

Ongoing

Date Initiated

12/05/2024

Location

Norderstedt, Germany

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

3 units

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).

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.

Distribution Pattern

US Nationwide distribution in the states of AL, FL.

Other Recalls by Waldemar Link GmbH & Co. KG (Mfg Site)

• Class II: Risk 11/10/2025
  The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
• Class II: Risk 07/31/2025
  Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
• Class II: Risk 07/15/2025
  Inconsistent size terminology and color coding used on labeling
• Class II: Risk 07/15/2025
  Inconsistent size terminology and color coding used on labeling
• Class II: Risk 04/03/2025
  The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

View all recalls by Waldemar Link GmbH & Co. KG (Mfg Site) →