Vanguard M Unicondylar Tibial Trial For use during knee joint… — Class II medical device recall Z-1798-2015
Terminated recall by Biomet, Inc., reported 2015-06-24, distributed in IL, NJ. The Left and Right orientation of the trial was incorrectly etched on one side. When the instrument is rotated
| Recall number | Z-1798-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2015-04-22 |
| Classified | 2015-06-15 |
| Reported by FDA | 2015-06-24 |
| Terminated | 2016-03-22 |
| Distributed | IL, NJ |
| Countries outside the US | CA, CL, NL |
| Quantity | 27 |
| Lot numbers | 024760, 070420, 073640, 116490, 414930, 670630, 672920, 785170, 785180, 785220, 785250, 785260, 785270, 785290, 873780 |
| Model numbers | 32-423101, 32-423102, 32-423106, 32-423107, 32-423108, 32-423109, 32-423110, 32-423115, 32-423116, 32-423119, 32-423124 |
Product
Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.
Reason for recall
The Left and Right orientation of the trial was incorrectly etched on one side. When the instrument is rotated about the axis of the handle 180 degrees to view the other side, the etch on the handle now shows R on the same side as the keel marked LM and the L on the same side as the keel marked RM. This is incorrect. Please note that the keel is not etched on this side by design.
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-1798-2015. 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.