Class II

Medical Device Recall: restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System

Conformis Inc. · March 25, 2025

Reason for Recall

The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.

Distribution

US Nationwide distribution in the states of CA, FL, NV, TN.

States Affected

NATIONWIDE

Quantity Affected

16

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1569-2025

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.