Recall Z-1952-2015 ยท EJI Syringe, Cartridge
Milestone Scientific, Inc.
Milestone Wand STA Handpiece for the delivery of local anesthesia to dental tissue. Model Number STA-5050-305. The Wand STA handpiece is a single use syringe used in conjunction with the CompuDent STA computer controlled dental injection system.
| Date | Jul 1, 2015 (initiated Feb 11, 2015) |
| Status | Terminated |
| Reason | Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the STA instrument. |
| Root cause | Nonconforming Material/Component |
| Action | Milestone Scientific notified their customers via e-mail and phone on 2/11/2015. |
| Quantity | 165,850 units |
| Distribution | Worldwide distribution. US in FL, IL, NY WA and Puerto Rico, Israel, Croatia, Italy, Australia, Germany, Colombia, UK, Sweden, and UAE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061904 | COMPUDENT STA Milestone Scientific, Inc., Aug 8, 2006 |