PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: August 17, 2022 Initiated: May 17, 2022 #Z-1510-2022

Product Description

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.

Details

Recalling Firm
Medical Modeling, Inc.
Units Affected
1 unit
Distribution
International distribution in the country of Germany.
Location
Littleton, CO

Frequently Asked Questions

What product was recalled?
3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile. Recalled by Medical Modeling, Inc.. Units affected: 1 unit.
Why was this product recalled?
Scapula Marking Guide (anatomically Shaped) was incorrectly designed.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 17, 2022. Severity: Moderate. Recall number: Z-1510-2022.