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Onkos Surgical, Inc. recalls My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Sho
Recalled July 9, 2025 · FDA recall Z-2042-2025 · Onkos Surgical
Hazard
Required inspections were not performed on finished product prior to release and distribution. · FDA Class II
Units
1 unit
Sold at
US Nationwide distribution in the state of Maryland.
Description
Required inspections were not performed on finished product prior to release and distribution.
Product
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
Manufacturer(s)
Onkos Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →