Class 3 Device Recall Milestone Scientific Wand STA Handpiece

• Date Initiated by Firm: February 11, 2015
• Date Posted: July 01, 2015
• Recall Status: Terminated on September 20, 2016
• Recall Number: Z-1952-2015
• Recall Event ID: 70742
• 510(K)Number: K061904
• Product Classification: Syringe, cartridge - Product Code EJI
• 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.
• Code Information: Lot 140103
• FEI Number: 3004082685
• Recalling Firm/ Manufacturer: Milestone Scientific, Inc.; 220 S Orange Ave; Livingston NJ 07039-5804
• For Additional Information Contact: Ms. Joyce Freeman; 973-535-2717
• Manufacturer Reason for Recall: Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the STA instrument.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Milestone Scientific notified their customers via e-mail and phone on 2/11/2015.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = EJI