Device product
Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 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.
Z-0200-2018
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 77479
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9
- Official record key
device-enforcement:Z-0200-2018
Official wording
Reason: Possible inner labeling and packaged device not matching the outer label on the box.
Code information: Catalog Number 350-21-13, Serial Range 4536756 - 4536764, Expiration August 2024
Distribution pattern: Distributed in North Carolina
Derived failure modes
-
Unknown
Possible inner labeling and packaged device not matching the outer label on the box.