Health product recall

ATTUNE™ AFFIXIUM™ Knee System Tibial Base

Brand(s)
Last updated

Summary

Product
ATTUNE™ AFFIXIUM™ Knee System Tibial Base
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

ATTUNE™ AFFIXIUM™ Knee System Tibial Base

JA06A0252

1506-21-006

Issue

Depuy Ireland Uc has initiated a medical device recall (removal) of one lot of the ATTUNE™ Cementless FB Tibial Base due to incorrect labeling. 3 complaints were received for incorrect labeling associated with the subject product including incorrect inner patient label (inner patient label was for a size 8, carton and product were both size 6), as well as the outer carton labeled as size 6 but contained a size 8 affixium tibial base. No adverse events have been reported.

Recall start date: March 13, 2024

Additional information

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

Depuy Ireland Uc

Loughbeg, Ringaskiddy, Cork, Ireland

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75285

Get notified

Receive notifications for new and updated recalls and alerts by category.

Subscribe