Product Wiki · Recalls · U.S. FDA — Device Enforcement

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; 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 sap

U.S. FDA — Device Enforcement · United States · 2016-09-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2916-2016
Date of alert: 2016-09-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: New Star Lasers, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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