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
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- 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 / hazard
- 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
- Status
- Ongoing
- Distribution / sold at
- Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
- Recall initiated
- 2026-07-06
- Code info
- UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069
- Product quantity
- 1 US; 9 OUS
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Norderstedt
- Country
- Germany
- Event id
- 99405
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