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DePuy Orthopaedics, Inc. recalls Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
Recalled March 29, 2023 · FDA recall Z-1265-2023 · DePuy Orthopaedics
Hazard
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. · FDA Class II
Units
7 units
Sold at
Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand
Description
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.
Product
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
Manufacturer(s)
DePuy Orthopaedics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →