FDA recall Z-2042-2025

Onkos Surgical, Inc. · Class II · device

Product

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

Reason for recall

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

Distribution

US Nationwide distribution in the state of Maryland.

Key facts

Status
Ongoing
Initiation date
2025-05-20
Report date
2025-07-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2042-2025