Vanguard Knee System -PS Open Box Femoral Left — Class II medical device recall Z-0495-2019
Terminated recall by Zimmer Biomet, Inc., reported 2018-11-28, distributed in AR, MN, MO, NJ, NY, OH, VA. Label on the outer carton or the patient labels does not match label on the inner sterile packaging
| Recall number | Z-0495-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-10-22 |
| Classified | 2018-11-21 |
| Reported by FDA | 2018-11-28 |
| Terminated | 2019-12-11 |
| Distributed | AR, MN, MO, NJ, NY, OH, VA |
| Quantity | 8 units |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 00880304270794 |
| Lot numbers | J6255863 |
| Model numbers | 183126 |
Product
Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
Reason for recall
Label on the outer carton or the patient labels does not match label on the inner sterile packaging
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-0495-2019. 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.