Recall Z-1510-2022 ยท DZJ Driver, Wire, And Bone Drill, Manual
Medical Modeling, Inc.
3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
| Date | May 17, 2022 |
| Status | Open, Classified |
| Reason | Scapula Marking Guide (anatomically Shaped) was incorrectly designed. |
| Root cause | Employee error |
| Action | 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. |
| Quantity | 1 unit |
| Distribution | International distribution in the country of Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133907 | VSP SYSTEM Medical Modeling, Inc., Jan 22, 2014 |