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

Hazard

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.

Details from the source

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: 1 US; 9 OUS Lot/code info: UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069

UPC codes

04026575432134

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.