FDAFDA · Food and drugs·Recall number Z-2926-2020
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Published September 9, 2020 · Recall initiated: August 10, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Exactech, Inc.
- Distributor
- Domestic: CO,FL,OK, PA. International: Chile
- Lot
- Catalog Number: 350-22-44 Lot numbers: 05144883 and 05144884 Serial Numbers: 6417984, 6417989, 6417996, 6417997, 6417998, 6418002, 6418003, 6488668, 6488673,6488674,6488675.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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