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

Recall Z-1681-2020 — Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391 Used in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

U.S. FDA — Device Enforcement · United States · 2019-12-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1681-2020
Date of alert
2019-12-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Solta Medical Inc
Product category
device
Product type
Devices
Reported risk: Complaints of sparking of the tips of the electrosurgical device used in RF surgical procedures. The use of the affected treatment tips could contribute to potential skin burns.
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.

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