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Exactech, Inc. recalls Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with an
Recalled December 13, 2017 · FDA recall Z-0200-2018 · Exactech
Hazard
Possible inner labeling and packaged device not matching the outer label on the box. · FDA Class II
Units
9
Sold at
Distributed in North Carolina
Description
Possible inner labeling and packaged device not matching the outer label on the box.
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.
Manufacturer(s)
Exactech, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →