FDA Device recall Z-0201-2018
Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc
- FDA Device
- Class II
- terminated
- Published 2017-12-13
On 2017-12-13 the FDA classified a Class II recall of Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc by Exactech, citing possible inner labeling and packaged device not matching the outer label on the box.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0201-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-16 |
| Published | 2017-12-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Exactech |
| Distribution | NC |
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
Possible inner labeling and packaged device not matching the outer label on the box.
Identifiers
| code_info | Catalog Number 350-21-43, Serial Range 4537323 - 4537331, Expiration August 2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0201-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.