Restor3d Cordera Hip System recalled over labeling errors

Recall date

March 25, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Conformis Inc. recalls restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Co…

Recall number

Z-1569-2025

FDA classification

Class II

Brand / firm

Conformis Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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