Device recall
Z-0201-2018: Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech…
FDA device recall · Class II · Exactech, Inc.
Key facts
| Recall number (Z-number) | Z-0201-2018 |
|---|---|
| Recall event | 77479 |
| 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… |
| Product code | HSN |
| Recalling firm | Exactech, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 22, 2021 |
| 510(k) numbers | K152217 |
| FEI number | 1038671 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database