My3D Personalized Solutions Humeral Cup — Class II medical device recall Z-2042-2025
Ongoing recall by Onkos Surgical, Inc., reported 2025-07-09, distributed nationwide. Required inspections were not performed on finished product prior to release and distribution.
| Recall number | Z-2042-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Onkos Surgical, Inc., Parsippany, NJ, United States |
| Recall initiated | 2025-05-20 |
| Classified | 2025-06-27 |
| Reported by FDA | 2025-07-09 |
| Distributed | Nationwide (US) |
| Quantity | 1 units |
| Serial numbers | C24-0223 |
| Model numbers | C24-0223-0003 |
Product
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
Reason for recall
Required inspections were not performed on finished product prior to release and distribution.
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-2042-2025. 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.