Vantage Total Ankle Tibial Insert — Class II medical device recall Z-0201-2018
Terminated recall by Exactech, Inc., reported 2017-12-13, distributed in NC. Possible inner labeling and packaged device not matching the outer label on the box.
| Recall number | Z-0201-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2017-05-16 |
| Classified | 2017-12-06 |
| Reported by FDA | 2017-12-13 |
| Terminated | 2021-04-22 |
| Distributed | NC |
| Quantity | 9 |
| Reason classes | labeling |
| Model numbers | 350-21-43 |
| Expiration dates | 2024-08-20 |
Product
Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. Indicated for cemented use only.
Reason for recall
Possible inner labeling and packaged device not matching the outer label on the box.
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-0201-2018. 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.