Device product
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.
Z-1952-2015
Product summary
- Event
- Event 70742
- Status
- Terminated
- Classification
- Class III
- Quantity
- 165,850 units
- Official record key
device-enforcement:Z-1952-2015
Official wording
Reason: Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the STA instrument.
Code information: Lot 140103
Distribution pattern: Worldwide distribution. US in FL, IL, NY WA and Puerto Rico, Israel, Croatia, Italy, Australia, Germany, Colombia, UK, Sweden, and UAE.
Derived failure modes
-
Labeling or packaging
mislabeled