Conformis Inc.: Device Recall
Recall #Z-1569-2025 · 03/25/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1569-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Conformis Inc.
- Status
- Ongoing
- Date Initiated
- 03/25/2025
- Location
- Wilmington, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16
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.
Product Description
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
Distribution Pattern
US Nationwide distribution in the states of CA, FL, NV, TN.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.