restor3d Cordera Hip System — Class II medical device recall Z-1569-2025
Ongoing recall by Conformis Inc., reported 2025-04-23, distributed nationwide. The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 containe
| Recall number | Z-1569-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Conformis Inc., Wilmington, MA, United States |
| Recall initiated | 2025-03-25 |
| Classified | 2025-04-15 |
| Reported by FDA | 2025-04-23 |
| Distributed | Nationwide (US) |
| Quantity | 16 |
| Reason classes | labeling |
| Lot numbers | 1788258 |
| Model numbers | HDL-060-C22L-000101 |
Product
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1569-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.