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U.S. Department of Health and Human Services

Class 3 Device Recall Milestone Scientific Wand STA Handpiece

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  Class 3 Device Recall Milestone Scientific Wand STA Handpiece see related information
Date Initiated by Firm February 11, 2015
Date Posted July 01, 2015
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = MILESTONE SCIENTIFIC, INC.
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