Recall Z-1952-2015— Milestone Scientific, Inc.
Class III · Terminated
Class III FDA medical device recall by Milestone Scientific, Inc., initiated 2015-02-11, terminated 2016-09-20. It names one FDA 510(k) clearance: K061904. 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.. Reason: Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the STA instrument..
- Recalling firm
- Milestone Scientific, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2015-02-11
- Terminated
- 2016-09-20
- Firm location
- Livingston, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.