FDA-Device2017-12-13Class II
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.
Exactech, Inc.
Hazard
Possible inner labeling and packaged device not matching the outer label on the box.
Sold states
Distributed in North Carolina
Affected count
9
Manufactured in
2320 NW 66th Ct, N/A, Gainesville, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0200-2018Don't want to check this manually?
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