FDA Enforcement
Class II
Terminated
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.
Recall: Z-0200-2018
·
Reported December 13, 2017
Enforcement
- Recall Number
- Z-0200-2018
- Event ID
- 77479
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Exactech, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 13, 2017
- Initiation Date
- May 16, 2017
- Classification Date
- December 6, 2017
- Termination Date
- April 22, 2021
- Address
- 2320 NW 66th Ct, N/A, Gainesville, FL, 32653-1630, United States
Description
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.
Reason
Possible inner labeling and packaged device not matching the outer label on the box.
Code Info
Catalog Number 350-21-13, Serial Range 4536756 - 4536764, Expiration August 2024
Distribution
Distributed in North Carolina
Quantity
9