Z-1569-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 23, 2025
- Initiation Date
- March 25, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16
Product Description
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 Pattern
US Nationwide distribution in the states of CA, FL, NV, TN.
Code Information
Model Number: HDL-060-C22L-000101 UDI-DI: M572HDL060C22L011. Lot: 1788258