Attune Revision Limb Preservation System recall
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
Why was Attune Revision Limb Preservation System recalled?
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
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?
GTIN: 10603295491033; Lot: JP9022
- Product
- Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
- Recalling firm
- DePuy Orthopaedics, Inc.
- Quantity
- 7 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand
- Recall date
- March 29, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)