Device product
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.
Z-1607-2024
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 94310
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 19 units (1 US, 18 OUS)
- Official record key
device-enforcement:Z-1607-2024
Official wording
Reason: Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
Code information: Item Number: 189082; Lot Number: 65966530; UDI-DI: (01)00880304436954(17)280413(10)65966530;
Distribution pattern: Worldwide distribution - US Nationwide in the state of IN and the countries of Canada, India, Netherlands, and P.R. China.
Derived failure modes
-
Unknown
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.