Health product recall

Attune System - Tibial Insert Fixed Bearing Posterior Stabilized

Brand(s)
Last updated

Summary

Product
Attune System - Tibial Insert Fixed Bearing Posterior Stabilized
Issue
Medical devices - Performance issue
What to do

Contact manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Attune System - Tibial Insert Fixed Bearing Posterior Stabilized

JN6613

1516-40-507

Issue

The subject lot was sent for sterilization twice. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the tibial insert material properties.

Recall start date: February 23, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Orthopaedics
Companies

Depuy (Ireland)

Loughbeg, Ringaskiddy, Cork, Ireland

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73008

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