Recall Z-2042-2025— Onkos Surgical, Inc.
Class II · Ongoing
Class II FDA medical device recall by Onkos Surgical, Inc., initiated 2025-05-20. FDA's recall record names no specific 510(k) clearance for this event. Product: My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device. Reason: Required inspections were not performed on finished product prior to release and distribution..
- Recalling firm
- Onkos Surgical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-05-20
- Firm location
- Parsippany, NJ, United States
Product description
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
Reason for recall
Required inspections were not performed on finished product prior to release and distribution.
Data sourced from openFDA. This site is unofficial and independent of the FDA.