FDA-Device2025-07-09Class II
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
Onkos Surgical, Inc.
Hazard
Required inspections were not performed on finished product prior to release and distribution.
Sold states
US Nationwide distribution in the state of Maryland.
Affected count
1 unit
Manufactured in
77 E Halsey Rd, Parsippany, NJ, United States
Products
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2042-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief