Z-2042-2025 Class II Ongoing
FDA device recall Z-2042-2025 was initiated by Onkos Surgical, Inc. on May 20, 2025 and is designated Class II. Reason for recall: Required inspections were not performed on finished product prior to release and distribution. The recall status is ongoing. Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- July 9, 2025
- Initiation Date
- May 20, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
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.
Distribution Pattern
US Nationwide distribution in the state of Maryland.
Code Information
Model Number: C24-0223-0003. UDI-DI #: N/A. Serial #: C24-0223