Vantage Total Ankle Tibial Insert recall: Labeling Error
Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by severe…
Why was Vantage Total Ankle Tibial Insert recalled?
Possible inner labeling and packaged device not matching the outer label on the box.
What should I do if I have this product?
Review the official FDA enforcement record for current 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 350-21-43, Serial Range 4537323 - 4537331, Expiration August 2024
- Product
- Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by severe…
- Recalling firm
- Exactech, Inc.
- Quantity
- 9
- Distribution
- Distributed in North Carolina
- Recall date
- December 13, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)