Recall Z-1510-2022
Medical Modeling, Inc. · initiated May 17, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
Codes / lots: Lot # 167559; UDI: (01) 00816847020886
Reason for recall
Scapula Marking Guide (anatomically Shaped) was incorrectly designed.
FDA-determined 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.
Details
- Recall number
- Z-1510-2022
- Initiated
- May 17, 2022
- Product code
- DZJ – Driver, Wire, And Bone Drill, Manual
- Quantity
- 1 unit
- Distribution
- International distribution in the country of Germany.
- Recalling firm
- Medical Modeling, Inc., Littleton, CO