restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
This recall is currently active, issued April 15, 2025. It was issued by Conformis Inc..
- Company
- Conformis Inc.
- Recall Initiated
- March 25, 2025
- Posted
- April 15, 2025
- Recall Number
- Z-1569-2025
- Quantity
- 16
- Firm Location
- Wilmington, MA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Model Number: HDL-060-C22L-000101 UDI-DI: M572HDL060C22L011. Lot: 1788258
Root Cause
Labeling Change Control
Action Taken
On about 03/25/2025, Conformis notified consignees via email with letter titled "URGENT: MEDICAL DEVICE RECALL." Consignees were instructed to examine inventory, quarantine any affected units on hand, and make arrangements to return the product. Additionally, consignees were asked to complete and return the response portion of the letter.