The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Reported: September 9, 2020 Initiated: August 10, 2020 #Z-2926-2020
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.
Details
- Recalling Firm
- Exactech, Inc.
- Units Affected
- 11 units
- Distribution
- Domestic: CO,FL,OK, PA. International: Chile
- Location
- Gainesville, FL
Frequently Asked Questions
What product was recalled? ▼
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.. Recalled by Exactech, Inc.. Units affected: 11 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 9, 2020. Severity: Moderate. Recall number: Z-2926-2020.
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