Device Class II · moderate Ongoing Aug 19, 2026

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.

Recalling firm	Waldemar Link GmbH & Co. KG (Mfg Site)
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.
Risk class	Class II (Class II · moderate)
Status	Ongoing
Report date	Aug 19, 2026
Initiated	Jul 6, 2026
Region	Germany
Distribution	Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
Quantity	1 US; 9 OUS
Code/Lot	UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069
Type	Voluntary: Firm initiated
Recall number	Z-2934-2026

Official source

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