FDA recall Z-1569-2025

Conformis Inc. · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2025-03-25
Report date
2025-04-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wilmington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1569-2025