FDA Device recall Z-2916-2016
ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue
- FDA Device
- Class II
- terminated
- Published 2016-10-12
On 2016-10-12 the FDA classified a Class II recall of ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue by New Star Lasers, citing 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 ind….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2916-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-19 |
| Published | 2016-10-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | New Star Lasers |
| Distribution | n/a |
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
Reason
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.
Identifiers
| code_info | Serial numbers: ABKK03 ABKK04 ABKM02 ABSG01 ABUP01. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2916-2016%22
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