Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

My3D Personalized Solutions Humeral Cup Recalled by Onkos Surgical, Inc. Due to Required inspections were not performed on finished product...

Date: May 20, 2025
Company: Onkos Surgical, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Onkos Surgical, Inc. directly.

Affected Products

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

Quantity: 1 unit

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Onkos Surgical, Inc.

Onkos Surgical, Inc. has 16 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report