Onkos Surgical, Inc.: Device Recall

Recall #Z-2042-2025 · 05/20/2025

Class II: Risk

Recall Details

Recall Number: Z-2042-2025
Classification: Class II
Product Type: Device
Recalling Firm: Onkos Surgical, Inc.
Status: Ongoing
Date Initiated: 05/20/2025
Location: Parsippany, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1 unit

Reason for Recall

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

Product Description

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

Distribution Pattern

US Nationwide distribution in the state of Maryland.

Other Recalls by Onkos Surgical, Inc.

Class II: Risk 07/11/2025

Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Class II: Risk 07/11/2025

Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Class II: Risk 07/11/2025

Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Class II: Risk 09/22/2024

Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.

View all recalls by Onkos Surgical, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.