My3D Personalized Solutions Humeral Cup recall
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
Why was My3D Personalized Solutions Humeral Cup recalled?
Required inspections were not performed on finished product prior to release and distribution.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: C24-0223-0003. UDI-DI #: N/A. Serial #: C24-0223
- Product
- My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
- Recalling firm
- Onkos Surgical, Inc.
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of Maryland.
- Recall date
- July 9, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)