Waldemar Link GmbH & Co. KG (Mfg Site): LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50

Hazard

Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.

Details from the source

Reason for recall: Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect. Distribution: Worldwide - US Nationwide distribution in the states of CO, IN, NJ, TX and the countries of Germany and Italy. Quantity: 8 units Lot/code info: REF Number: 880-100/50. UDI-DI: 04026575251278. Serial Numbers: 210125/2259, 210125/2262, 210125/2268, 210125/2260, 210125/2264, 210125/2270, 210125/2272, 210125/2273.

UPC codes

04026575251278

Source

Official record: FDA (Device enforcement) ↗

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