Z-2916-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 12, 2016
- Initiation Date
- September 19, 2016
- Termination Date
- December 13, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 systems
Product Description
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
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.
Distribution Pattern
US distribution only.
Code Information
Serial numbers: ABKK03 ABKK04 ABKM02 ABSG01 ABUP01.