My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
Reported: July 9, 2025 Initiated: May 20, 2025 #Z-2042-2025
Product Description
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.
Details
- Recalling Firm
- Onkos Surgical, Inc.
- Units Affected
- 1 unit
- Distribution
- US Nationwide distribution in the state of Maryland.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device. Recalled by Onkos Surgical, Inc.. Units affected: 1 unit.
Why was this product recalled? ▼
Required inspections were not performed on finished product prior to release and distribution.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 9, 2025. Severity: Moderate. Recall number: Z-2042-2025.
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