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

Company

Medical Modeling, Inc.

Recall Initiated

May 17, 2022

Recall Number

Z-1510-2022

Quantity

1 unit

Firm Location

Littleton, CO

Reason for Recall

Scapula Marking Guide (anatomically Shaped) was incorrectly designed.

Distribution

International distribution in the country of Germany.

Lot / Code Info

Lot # 167559; UDI: (01) 00816847020886

Root Cause

Employee error

Action Taken

On May 17, 2022, Medical Modeling - A 3D systems Company representative contacted affected customer via phone and informed the consignee of the issue and their plan to remove the device and provide a new one.