Recall Z-2042-2025 ยท QHQ Total Shoulder Arthroplasty System
Onkos Surgical, Inc.
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
| Date | Jun 27, 2025 (initiated May 20, 2025) |
| Status | Open, Classified |
| Reason | Required inspections were not performed on finished product prior to release and distribution. |
| Root cause | Process control |
| Action | 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 implantat |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the state of Maryland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.