Biomet, Inc.: Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane ba

Hazard

Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.

Details from the source

Reason for recall: Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process. Distribution: Worldwide distribution - US Nationwide in the state of IN and the countries of Canada, India, Netherlands, and P.R. China. Quantity: 19 units (1 US, 18 OUS) Lot/code info: Item Number: 189082; Lot Number: 65966530; UDI-DI: (01)00880304436954(17)280413(10)65966530;

UPC codes

00880304436954

Source

Official record: FDA (Device enforcement) ↗

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