FDA Device recall Z-2042-2025
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003
- FDA Device
- Class II
- ongoing
- Published 2025-07-09
On 2025-07-09 the FDA classified a Class II recall of My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003 by Onkos Surgical, citing required inspections were not performed on finished product prior to release and distribution.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2042-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-20 |
| Published | 2025-07-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Onkos Surgical |
| Distribution | US |
Product
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
Reason
Required inspections were not performed on finished product prior to release and distribution.
Identifiers
| code_info | Model Number: C24-0223-0003. UDI-DI #: N/A. Serial #: C24-0223 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2042-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.