TemporaryFDAOngoing
Can cause harm that is usually temporary.
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
Check the device or its packaging for
UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069
- Why
- 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.
- Distributed
- Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
- Company
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2934-2026 · retrieved 11 August 2026
Read the official notice