Device product
Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
Z-1266-2023
Product summary
- Event
- Event 91752
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7 units
- Official record key
device-enforcement:Z-1266-2023
Official wording
Reason: 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.
Code information: GTIN: 10603295490869; Lot: JP6464
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand
Derived failure modes
-
Unknown
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.