FDAFDA · Food and drugs·Recall number Z-0201-2018
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.
Published December 13, 2017 · Recall initiated: May 16, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Possible inner labeling and packaged device not matching the outer label on the box.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Exactech, Inc.
- Distributor
- Distributed in North Carolina
- Lot
- Catalog Number 350-21-43, Serial Range 4537323 - 4537331, Expiration August 2024
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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