Vanguard Knee System AS Tibial Bearing / DCM ArCom — Class II medical device recall Z-1607-2024
Ongoing recall by Biomet, Inc., reported 2024-05-01, distributed nationwide. Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
| Recall number | Z-1607-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2024-03-13 |
| Classified | 2024-04-22 |
| Reported by FDA | 2024-05-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, IN, NL |
| UPC / GTIN / UDI-DI | 00880304436954 |
| Lot numbers | 65966530 |
| Model numbers | 189082 |
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 for recall
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1607-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.