Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block… — Class II medical device recall Z-3249-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-10-03, distributed nationwide. The implant only has one bolt in the sterile package but it should have had two.
| Recall number | Z-3249-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-08-02 |
| Classified | 2018-09-25 |
| Reported by FDA | 2018-10-03 |
| Terminated | 2019-04-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, NL |
| Quantity | 16 |
| Reason classes | sterility |
| Lot numbers | 320390 |
| Model numbers | 185221 |
Product
Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty
Reason for recall
The implant only has one bolt in the sterile package but it should have had two.
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-3249-2018. 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.