Recall Z-2042-2025
Onkos Surgical, Inc. · initiated May 20, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
Codes / lots: Model Number: C24-0223-0003. UDI-DI #: N/A. Serial #: C24-0223
Reason for recall
Required inspections were not performed on finished product prior to release and distribution.
FDA-determined cause: Process control
Action taken
The firm notified the single customer via telephone call on 05/20/2025 and it was followed up with a letter emailed on 05/29/2025. The notification instructed the customer to segregate and quarantine the component immediately and return the implant component in question within 2 business days of acknowledgment of notification. The component was returned on 05/22/2025. Distributors have responsibility for maintaining field inventory and are responsible for the inventory, even if located on site at a hospital as the products are not purchased/owned by the hospital or patient prior to implantation.
Details
- Recall number
- Z-2042-2025
- Initiated
- May 20, 2025
- Posted by FDA
- June 27, 2025
- Product code
- QHQ – Total Shoulder Arthroplasty System
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of Maryland.
- Recalling firm
- Onkos Surgical, Inc., Parsippany, NJ