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.
Reported: December 13, 2017 Initiated: May 16, 2017 #Z-0201-2018
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.
Details
- Recalling Firm
- Exactech, Inc.
- Units Affected
- 9
- Distribution
- Distributed in North Carolina
- Location
- Gainesville, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Exactech, Inc.. Units affected: 9.
Why was this product recalled? ▼
Possible inner labeling and packaged device not matching the outer label on the box.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 13, 2017. Severity: Moderate. Recall number: Z-0201-2018.
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