FDA-Device2022-08-17Class II
3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
Medical Modeling, Inc.
Hazard
Scapula Marking Guide (anatomically Shaped) was incorrectly designed.
Sold states
International distribution in the country of Germany.
Affected count
1 unit
Manufactured in
5381 S Alkire Cir, Littleton, CO, United States
Products
3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1510-2022Don't want to check this manually?
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