Waldemar Link & Co. KG (Mfg Site) recalls

Recall found. Waldemar Link & Co. KG (Mfg Site) is named in FDA Class II recall Z-2934-2026 covering Endo-Model. 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. Identifying details: UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069. Status: Ongoing.