Official recall record
ATTUNE™ AFFIXIUM™ Knee System Tibial Base
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-03-22
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.