Recall Z-2926-2020— Exactech, Inc.
Class II · Ongoing
Class II FDA medical device recall by Exactech, Inc., initiated 2020-08-10. It names one FDA 510(k) clearance: K152217. Product: The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.. Reason: The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm because they were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 3 when the implant size is 4..
- Recalling firm
- Exactech, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-08-10
- 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
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Reason for recall
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm because they were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 3 when the implant size is 4.
Data sourced from openFDA. This site is unofficial and independent of the FDA.