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

Recall #Z-2289-2025 · 07/15/2025

Class II: Risk

Recall Details

Recall Number: Z-2289-2025
Classification: Class II
Product Type: Device
Recalling Firm: Waldemar Link GmbH & Co. KG (Mfg Site)
Status: Ongoing
Date Initiated: 07/15/2025
Location: Norderstedt, N/A, Germany
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 17 units

Reason for Recall

Inconsistent size terminology and color coding used on labeling

Product Description

Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.

Distribution Pattern

Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IN, KS, LA, NJ and the countries of Germany, Argentina, Belgium, Switzerland, Cyprus, Algeria, Finland, Hungary, Mexico, Netherlands, Peru, Slovenia, and Uruguay.

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 04/03/2025

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
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) →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.