Product Wiki · Recalls · Health Canada — Medical Devices

ATTUNE™ AFFIXIUM™ Knee System Tibial Base — recall 75285

Health Canada — Medical Devices · Canada · 2024-03-22 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
75285
Date of alert
2024-03-22
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Orthopaedics
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/attunetm-affixiumtm-knee-syste

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