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

FDA Recall #Z-1264-2023 — Class II — February 15, 2023

Recall #Z-1264-2023 Date: February 15, 2023 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

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.

Recalling Firm

DePuy Orthopaedics, Inc. — Warsaw, IN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

7 units

Distribution

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

Code Information

GTIN: 10603295490968; Lot: JP9016

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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