Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-
- Recalling company
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Product
- Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
- Reason
- The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 6, 2026
- Reported
- Aug 19, 2026
- Distribution
- Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
- Status
- Ongoing
- Quantity
- 1 US; 9 OUS
- Lot / codes
- UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069
- Company location
- Norderstedt
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2934-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2934-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.