My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder
FDA device recall Z-2042-2025 · posted 2025-06-27 · Open, Classified
Recall details
- Recalling firm
- Onkos Surgical, Inc.
- Reason for recall
- Required inspections were not performed on finished product prior to release and distribution.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- QHQ
- Quantity affected
- 1 unit
- Distribution
- US Nationwide distribution in the state of Maryland.
- Date initiated
- 2025-05-20
- Date posted
- 2025-06-27
- Location
- Parsippany, NJ
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