Class 2 Device Recall Thermage

• Date Initiated by Firm: December 09, 2002
• Date Posted: February 13, 2003
• Recall Status: Terminated on April 30, 2003
• Recall Number: Z-0556-03
• Recall Event ID: 25383
• Product Classification: Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
• Product: ThermaCool TC 1.0 cm2 Treatment Tip, Single Patient Use Only
• Code Information: M00023, M00024, M00029, M00031, M00033R, M00034, M00035,
• Recalling Firm/ Manufacturer: Thermage; 4058 Point Eden Way; Hayward CA 94545-3721
• For Additional Information Contact: Richard J. Meader; 510-259-7119
• Manufacturer Reason for Recall: Product tip has potential to liquid leakage into the internal circuitry causing malfunction and may result in epidermal injury.
• FDA Determined Cause: Other
• Action: The recall notification was faxed to all 54 consignees on 12/8/02. A follow-up hard copy of the recall notification was sent via FedEx on 12/9/02.
• Quantity in Commerce: 1,326 units
• Distribution: The product was distributed nationwide. A total of 54 consignees received the product. The recall was appropriately extended to the user level; i.e., the wholesalers/distributors, hospitals and medical supply distributors, and physicians who received the recalled product. There is no known U. S. Government or Canadian distribution.
• 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.