Public recall detail

Attune System - Tibial Insert Fixed Bearing Posterior Stabilized

2023-03-03

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Recall Safety notice
Quick summary

Quick summary: Attune System - Tibial Insert Fixed Bearing Posterior Stabilized. Date: 2023-03-03.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Attune System - Tibial Insert Fixed Bearing Posterior Stabilized. Date: 2023-03-03.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandDepuy
ProductAttune System - Tibial Insert Fixed Bearing Posterior Stabilized
IssueMedical devices - Performance
Recall classType II
IdentificationRA-73008

Affected products

ProductAttune System - Tibial Insert Fixed Bearing Posterior Stabilized
LotJN6613
Model1516-40-507
Serial numberJN6613
DescriptionAttune System - Tibial Insert Fixed Bearing Posterior Stabilized

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

What you should do

  • Contact manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Orthopaedics
CompaniesDepuy (Ireland) Loughbeg, Ringaskiddy, Cork, Ireland
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-73008
Background{}
CompaniesDepuy (Ireland) Loughbeg, Ringaskiddy, Cork, Ireland
AudiencesHealthcare
Source updated2023-03-03

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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