The Vantage Total Ankle Tibial Insert — Class II medical device recall Z-2926-2020
Ongoing recall by Exactech, Inc., reported 2020-09-09, distributed in CO, FL, OK, PA. The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error.
| Recall number | Z-2926-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2020-08-10 |
| Classified | 2020-08-31 |
| Reported by FDA | 2020-09-09 |
| Distributed | CO, FL, OK, PA |
| Countries outside the US | CL |
| Quantity | 11 units |
| Reason classes | labeling |
| Lot numbers | 05144883, 05144884 |
| Serial numbers | 6417984, 6417989, 6417996, 6417997, 6417998, 6418002, 6418003, 6488668, 6488673, 6488674, 6488675 |
| Model numbers | 350-22-44 |
Product
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Reason for recall
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm because they were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 3 when the implant size is 4.
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-2926-2020. 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.