Recall Z-1569-2025 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Conformis Inc.
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
| Date | Apr 15, 2025 (initiated Mar 25, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Labeling Change Control |
| 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. |
| Quantity | 16 |
| Distribution | US Nationwide distribution in the states of CA, FL, NV, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202484 | Cordera Hip System Conformis, Inc., Sep 24, 2020 |