My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a...
FDA Recall #Z-2042-2025 — Class II — May 20, 2025
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.
Recalling Firm
Onkos Surgical, Inc. — Parsippany, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1 unit
Distribution
US Nationwide distribution in the state of Maryland.
Code Information
Model Number: C24-0223-0003. UDI-DI #: N/A. Serial #: C24-0223
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated