Onkos Surgical, Inc. recalls My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulde…
- Recall date
- May 20, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2042-2025
- FDA classification
- Class II
- Brand / firm
- Onkos Surgical, Inc.
- Sold / distributed
- US Nationwide distribution in the state of Maryland.
Why it was recalled
Required inspections were not performed on finished product prior to release and distribution.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
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