Device product
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
Z-2042-2025
Product summary
- Event
- Event 97005
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-2042-2025
Official wording
Reason: Required inspections were not performed on finished product prior to release and distribution.
Code information: Model Number: C24-0223-0003. UDI-DI #: N/A. Serial #: C24-0223
Distribution pattern: US Nationwide distribution in the state of Maryland.
Derived failure modes
-
Unknown
Required inspections were not performed on finished product prior to release and distribution.