DePuy Orthopaedics, Inc. recalls Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212

Recall date

February 15, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1264-2023

FDA classification

Class II

Brand / firm

DePuy Orthopaedics, Inc.

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212