FDA Medical devices recall ·
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003… recall
- Recall number
- Z-2042-2025
- Date
- (initiated May 20, 2025)
- Company / brand
- Onkos Surgical, Inc.
77 E Halsey Rd, Parsippany, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1 unit
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
Why was it recalled?
Required inspections were not performed on finished product prior to release and distribution.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: C24-0223-0003. UDI-DI #: N/A. Serial #: C24-0223
Distribution
US Nationwide distribution in the state of Maryland.
States: Maryland
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2042-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.