Recall Z-0201-2018— Exactech, Inc.
Class II · Terminated
Class II FDA medical device recall by Exactech, Inc., initiated 2017-05-16, terminated 2021-04-22. It names one FDA 510(k) clearance: K152217. 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.. Reason: Possible inner labeling and packaged device not matching the outer label on the box..
- Recalling firm
- Exactech, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-16
- Terminated
- 2021-04-22
- Firm location
- Gainesville, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.