FDA Device recall Z-1607-2024
Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM
- FDA Device
- Class II
- ongoing
- Published 2024-05-01
On 2024-05-01 the FDA classified a Class II recall of Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM by Biomet, citing possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1607-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-13 |
| Published | 2024-05-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Biomet |
| Distribution | US |
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.
Reason
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
Identifiers
| code_info | Item Number: 189082; Lot Number: 65966530; UDI-DI: (01)00880304436954(17)280413(10)65966530; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1607-2024%22
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