Z-0201-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2017
- Initiation Date
- May 16, 2017
- Termination Date
- April 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9
Product Description
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 for Recall
Possible inner labeling and packaged device not matching the outer label on the box.
Distribution Pattern
Distributed in North Carolina
Code Information
Catalog Number 350-21-43, Serial Range 4537323 - 4537331, Expiration August 2024