FDA Enforcement
Class II
Ongoing
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
Recall: Z-2042-2025
·
Reported July 9, 2025
Enforcement
- Recall Number
- Z-2042-2025
- Event ID
- 97005
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Onkos Surgical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- July 9, 2025
- Initiation Date
- May 20, 2025
- Classification Date
- June 27, 2025
- Address
- 77 E Halsey Rd, Parsippany, NJ, 07054-3714, United States
Description
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.
Code Info
Model Number: C24-0223-0003. UDI-DI #: N/A. Serial #: C24-0223
Distribution
US Nationwide distribution in the state of Maryland.
Quantity
1 unit