restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cor
FDA device recall Z-1569-2025 · posted 2025-04-15 · Open, Classified
Recall details
- Recalling firm
- Conformis Inc.
- 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.
- 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.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- LPH
- Quantity affected
- 16
- Distribution
- US Nationwide distribution in the states of CA, FL, NV, TN.
- Date initiated
- 2025-03-25
- Date posted
- 2025-04-15
- Location
- Wilmington, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Cordera Hip System (K202484) | Conformis, Inc. | 2020-09-24 |