Biomet, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1607-2024)
See the recall detail below. You can also see other recalls from the same firm in 2024.
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 bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and sealed with Tyvek lid stock (outer barrier). The sealed double barrier system is placed into a paperboard carton with an IFU and label/indicator dots applied to the carton.
Class II
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
Item Number: 189082; Lot Number: 65966530; UDI-DI: (01)00880304436954(17)280413(10)65966530;
Worldwide distribution - US Nationwide in the state of IN and the countries of Canada, India, Netherlands, and P.R. China.
Voluntary: Firm initiated
