FDA Recall
Open, Classified
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
Recall: Z-1569-2025
·
Initiated March 25, 2025
Recall
- Recall Number
- Z-1569-2025
- Event Number
- 96606
- Firm
- Conformis Inc.
- FEI Number
- 3004153240
- Product Code
- LPH
- Status
- Open, Classified
- Root Cause
- Labeling Change Control
- Initiated
- March 25, 2025
- Posted
- April 15, 2025
- Address
- 600 Research Dr, Wilmington, MA, 01887-4437
Description
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
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.
Action
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.
Distribution
US Nationwide distribution in the states of CA, FL, NV, TN.
Quantity
16