Medical Device Recall: Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
Waldemar Link GmbH & Co. KG (Mfg Site) · July 6, 2026
Reason for Recall
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.
Distribution
Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
Quantity Affected
1 US; 9 OUS
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2934-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.