Device product
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
Z-1569-2025
Product summary
- Firm
- Conformis Inc.
- Event
- Event 96606
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16
- Official record key
device-enforcement:Z-1569-2025
Official wording
Reason: 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.
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.
Derived failure modes
-
Labeling or packaging
incorrect labeling