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U.S. Department of Health and Human Services

Class 2 Device Recall Thermage

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  Class 2 Device Recall Thermage see related information
Date Initiated by Firm December 09, 2002
Date Posted February 13, 2003
Recall Status1 Terminated 3 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 2		 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.
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