Endo-Model recall (Waldemar Link GmbH & Co. KG (Mfg Site))

Medical deviceClass IIOngoing

Summary: Waldemar Link GmbH & Co. KG (Mfg Site) is recalling Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16. 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.

What is being recalled

Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16

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.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Domestic US distribution to Indiana. OUS distribution to Belarus and Germany. (states named: Indiana)

How to tell if yours is affected

UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

More recalls from Waldemar Link GmbH & Co. KG (Mfg Site) · all medical device recalls · recalls from July 2026

Official FDA record