Exactech Vantage Ankle System recall
Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03
Why was Exactech Vantage Ankle System recalled?
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
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?
a) 350-21-04, GTIN 10885862276247, Serial Numbers: A644020; b) 350-22-03, GTIN 10885862276353, Serial Numbers: A641653, A641655, A641659, A641660, A641662, A641663, A641666, A641667, A641668, A641669, A641672, A641654
- Product
- Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03
- Recalling firm
- Exactech, Inc.
- Quantity
- N/A
- Distribution
- US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK
- Recall date
- December 27, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)