(1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended… — Class II medical device recall Z-1042-2023
Ongoing recall by Biomet, Inc., reported 2023-02-08, distributed in FL, IN, MD, OH, PA, WI. Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
| Recall number | Z-1042-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2022-12-29 |
| Classified | 2023-01-30 |
| Reported by FDA | 2023-02-08 |
| Distributed | FL, IN, MD, OH, PA, WI |
| Countries outside the US | AR, CN, CR, EC, IN, JP, KR, MX, NL, SG, TH |
| Quantity | 157 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00880304270770, 00880304270787, 00880304270794, 00880304270817 |
| Lot numbers | J7209534 |
| Model numbers | 183104, 183106, 183108, 183110, 183112 |
Product
(1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm Item Number: 183106 (3) Vanguard Knee System PS Open Box Femoral; Right; 65 mm Item Number: 183108 (4) Vanguard Knee System PS Open Box Femoral; Right; 67.5 mm Item Number: 183110 (5) Vanguard Knee System PS Open Box Femoral; Right; 70 mm Item Number: 183112
Reason for recall
Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
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-1042-2023. 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.