Device product
3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
Z-1510-2022
Product summary
- Event
- Event 90672
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-1510-2022
Official wording
Reason: Scapula Marking Guide (anatomically Shaped) was incorrectly designed.
Code information: Lot # 167559; UDI: (01) 00816847020886
Distribution pattern: International distribution in the country of Germany.
Derived failure modes
-
Unknown
Scapula Marking Guide (anatomically Shaped) was incorrectly designed.