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...
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.
About Onkos Surgical, Inc.
Onkos Surgical, Inc. has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report