Exactech Alteon Hip XLE Liner recall
Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
Why was Exactech Alteon Hip XLE Liner 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) 01-030-40-0636, GTIN 10885862549655, Serial Numbers: A678476, A678485, A678486, A678495, A678508, A678516, A678819, A678820, A678822, A678826, A678827, A678832, A678845, A678847, A678855, A678859, A678863; b) 01-030-40-0640, GTIN 10885862549662, Serial Numbers: A746645, A746649; c) 01-030-42-0536, GTIN 10885862549945, Serial Numbers: A655570, A655573, A655574
- Product
- Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
- 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)