Class II

Medical Device Recall: Identity Imprint PS Tibial Tray Size 4: Lot 540287

Conformis, Inc. · March 11, 2024

Reason for Recall

Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.

Distribution

US Nationwide distribution in the states of FL, KS and NH.

States Affected

NATIONWIDE

Quantity Affected

3 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1591-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.