Z-1952-2015 Class III Terminated
FDA device recall Z-1952-2015 was initiated by Milestone Scientific, Inc. on February 11, 2015 and is designated Class III. Reason for recall: Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the STA instrument. The recall status is terminated (terminated September 20, 2016). Affected quantity: 165,850 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2015
- Initiation Date
- February 11, 2015
- Termination Date
- September 20, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 165,850 units
Product Description
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.
Reason for Recall
Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the STA instrument.
Distribution Pattern
Worldwide distribution. US in FL, IL, NY WA and Puerto Rico, Israel, Croatia, Italy, Australia, Germany, Colombia, UK, Sweden, and UAE.
Code Information
Lot 140103