Waldemar Link GmbH & Co. KG (Mfg Site) 2025-05-07 Health serious FDA
Health · FDA · Recall #FDA-Z-1702-2025
Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12… Recall
Issued May 7, 2025 · Waldemar Link GmbH & Co. KG (Mfg Site)
In May 2025, Waldemar Link GmbH & Co. KG (Mfg Site) recalled the Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
What you should do
- 1 Stop using Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Waldemar Link GmbH & Co. KG (Mfg Site) to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Category
- Health
- Recall date
- May 7, 2025
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IN, IL, KS, LA, MD, MO, NV, OH, TX, VA, WI.
- Recall number
- FDA-Z-1702-2025
- Made in
- Germany
- Issuing agency
- FDA
In context
- Waldemar Link GmbH & Co. KG (Mfg Site) has 8 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.