DePuy Orthopaedics, Inc. 2023-03-29 Health serious FDA
Health · FDA · Recall #FDA-Z-1263-2023
Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number… Recall
Issued March 29, 2023 · DePuy Orthopaedics, Inc.
In March 2023, DePuy Orthopaedics, Inc. recalled the Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact DePuy Orthopaedics, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- DePuy Orthopaedics, Inc.
- Category
- Health
- Recall date
- March 29, 2023
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand
- Recall number
- FDA-Z-1263-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- DePuy Orthopaedics, Inc. has 4 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.