Onkos Surgical, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2042-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 20, 2025

Date Posted: July 9, 2025

Recall Number: Z-2042-2025

Event ID: 97005

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1 unit

Code Information:

Model Number: C24-0223-0003. UDI-DI #: N/A. Serial #: C24-0223

Distribution Pattern:

US Nationwide distribution in the state of Maryland.

Voluntary or Mandated:

Voluntary: Firm initiated