FDA recall Z-1510-2022

Medical Modeling, Inc. · Class II · device

Product

3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile

Reason for recall

Scapula Marking Guide (anatomically Shaped) was incorrectly designed.

Distribution

International distribution in the country of Germany.

Key facts

Status
Ongoing
Initiation date
2022-05-17
Report date
2022-08-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Littleton, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1510-2022