CONFORMIS HIP-SCREW-6 — Class II medical device recall Z-2405-2023
Ongoing recall by Conformis, Inc., reported 2023-08-23, distributed nationwide. 30mm screws were labeled as 25mm screws.
| Recall number | Z-2405-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Conformis, Inc., Billerica, MA, United States |
| Recall initiated | 2023-06-16 |
| Classified | 2023-08-16 |
| Reported by FDA | 2023-08-23 |
| Distributed | Nationwide (US) |
| Quantity | 25 units |
| Reason classes | labeling |
| Lot numbers | 1232071 |
| Model numbers | HAA-030-0625-000101 |
Product
CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
Reason for recall
30mm screws were labeled as 25mm screws.
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-2405-2023. 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.