Class II

Medical Device Recall: My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device

Onkos Surgical, Inc. · May 20, 2025

Reason for Recall

Required inspections were not performed on finished product prior to release and distribution.

Distribution

US Nationwide distribution in the state of Maryland.

States Affected

NATIONWIDE

Quantity Affected

1 unit

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2042-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Onkos Surgical, Inc. Medical Device Recall: My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device | SafeCheck