The Vantage Total Ankle Tibial Insert recall: Labeling Error
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Why was The Vantage Total Ankle Tibial Insert 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number: 350-22-44 Lot numbers: 05144883 and 05144884 Serial Numbers: 6417984, 6417989, 6417996, 6417997, 6417998, 6418002, 6418003, 6488668, 6488673,6488674,6488675.
- Product
- The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
- Recalling firm
- Exactech, Inc.
- Quantity
- 11 units
- Distribution
- Domestic: CO,FL,OK, PA. International: Chile
- Recall date
- September 9, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)