My3D Humeral Cup (Onkos Surgical) – Inspection Failure (2025)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
Brand
Onkos Surgical, Inc.
Lot Codes / Batch Numbers
Model Number: C24-0223-0003. UDI-DI #: N/A. Serial #: C24-0223
Products Sold
Model Number: C24-0223-0003. UDI-DI #: N/A. Serial #: C24-0223
Onkos Surgical, Inc. is recalling My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Cust due to Required inspections were not performed on finished product prior to release and distribution.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Required inspections were not performed on finished product prior to release and distribution.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026