3D Systems VSP Reconstruction recalled over sterility concerns
- Recall date
- May 17, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Medical Modeling, Inc. recalls 3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Steri…
- Recall number
- Z-1510-2022
- FDA classification
- Class II
- Brand / firm
- Medical Modeling, Inc.
- Sold / distributed
- International distribution in the country of Germany.
Why it was recalled
Scapula Marking Guide (anatomically Shaped) was incorrectly designed.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
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