Biomet, Inc. Recall 94310
Description: 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.
Biomet, Inc. Recall 94310 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1607-2024 |
| Event ID | 94310 |
| Event Description | 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. |
| Product Type | Devices |
| 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) |
| Recall Reason | Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process. |
| Device Classification | 20240501 |
| Device Code Info | Item Number: 189082; Lot Number: 65966530; UDI-DI: (01)00880304436954(17)280413(10)65966530; |
| Center Classification Date | 20240422 |
| Recall Initiation Date | 20240313 |
| Recalling Firm | Biomet, Inc. |
| Initial Notification | |
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