Device recall
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
- Recall number
- Z-2934-2026
- Event id
- 99405
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Report date
- Aug 19, 2026
- Initiated
- Jul 6, 2026
- Center classification date
- Aug 11, 2026
- 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.
- Quantity
- 1 US; 9 OUS
- Code info
- UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069
- Distribution
- Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Norderstedt, Germany