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
|