FDA Device recall Z-2926-2020
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm
- FDA Device
- Class II
- ongoing
- Published 2020-09-09
On 2020-09-09 the FDA classified a Class II recall of The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm by Exactech, citing 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 B….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2926-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-08-10 |
| Published | 2020-09-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Exactech |
| Distribution | CO, FL, OK, PA |
Product
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Reason
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.
Identifiers
| code_info | Catalog Number: 350-22-44 Lot numbers: 05144883 and 05144884 Serial Numbers: 6417984, 6417989, 6417996, 6417997, 641…Catalog Number: 350-22-44 Lot numbers: 05144883 and 05144884 Serial Numbers: 6417984, 6417989, 6417996, 6417997, 6417998, 6418002, 6418003, 6488668, 6488673,6488674,6488675. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2926-2020%22
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