Conformis Inc.: Medical Device Recall in 2025 - (Recall #: Z-1569-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.
Product Description:

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

Product Classification:

Class II

Date Initiated: March 25, 2025
Date Posted: April 23, 2025
Recall Number: Z-1569-2025
Event ID: 96606
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.

Status: Ongoing
Product Quantity: 16
Code Information:

Model Number: HDL-060-C22L-000101 UDI-DI: M572HDL060C22L011. Lot: 1788258

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated