Class 2 Device Recall ReNew

• Date Initiated by Firm: September 19, 2016
• Create Date: September 30, 2016
• Recall Status: Terminated on December 13, 2016
• Recall Number: Z-2916-2016
• Recall Event ID: 75048
• Product Classification: Powered laser surgical instrument - Product Code GEX
• Product: ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for use in the treatment of fine lines and wrinkles; for treatment of back acne and atrophic acne scars; for treatment of reflux of the great and small saphenous veins associated with varicose veins and varicosities, and; for laser assisted lipolysis
• Code Information: Serial numbers: ABKK03 ABKK04 ABKM02 ABSG01 ABUP01.
• Recalling Firm/ Manufacturer: New Star Lasers, Inc.; 9085 Foothills Blvd; Roseville CA 95747-7130
• For Additional Information Contact: Nina Davis; 916-677-1909
• Manufacturer Reason for Recall: FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.
• FDA Determined Cause: Labeling False and Misleading
• Action: Letters sent on September 19, 2016 via US mail advised customers of the unapproved claims that may be in their literature and advised of the approved uses for each device.
• Quantity in Commerce: 5 systems
• Distribution: US distribution only.
• 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.