Waldemar Link GmbH & Co. KG (Mfg Site) — Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
⚠️ 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.
Is this relevant to me?
- Geography
- US
- Source agency
- FDA
- Category
- Health
- Published
- July 6, 2026
Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
What's affected?
- Product
- Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
- Lot code
- for
Additional details
UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1 US; 9 OUS.
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