medical MODERATE Updated 2017-12-13

Exactech, Inc. recalls Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Lef

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Recalled Product

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.

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Hazard / Issue

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

Issued by

FDA

Distribution: Distributed in North Carolina
Lot/Code Info: Catalog Number 350-21-43, Serial Range 4537323 - 4537331, Expiration August 2024

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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