FDA-Device2023-03-29Class II
Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
DePuy Orthopaedics, Inc.
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand
Affected count
12 units
Manufactured in
700 Orthopaedic Dr, N/A, Warsaw, IN, United States
Products
Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1267-2023Don't want to check this manually?
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