Exactech, Inc. recalls Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle j…

Recall date

May 16, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0201-2018

FDA classification

Class II

Brand / firm

Exactech, Inc.

Sold / distributed

Distributed in North Carolina

Why it was recalled

Possible inner labeling and packaged device not matching the outer label on the box.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.