ATTUNE™ AFFIXIUM™ Knee System Tibial Base

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