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U.S. Department of Health and Human Services

Class 2 Device Recall Electrosurgical pencil

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  Class 2 Device Recall Electrosurgical pencil see related information
Date Initiated by Firm March 29, 2010
Date Posted May 10, 2010
Recall Status1 Terminated 3 on September 27, 2010
Recall Number Z-1565-2010
Recall Event ID 55189
510(K)Number K791137  
Product Classification Electrosurgical, cutting; coagulation & accessories - Product Code GEI
Product ConMed Goldline Hand Controlled With Blade Electrode, Rocker Switch, Safety Holster and 10 FT Cable, REF 130319A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502.
Code Information Lot code range: 0903253 through 1002143
Recalling Firm/
Manufacturer
ConMed Electrosurgery
14603 E Fremont Ave
Centennial CO 80112-4251
For Additional Information Contact
303-269-8237
Manufacturer Reason
for Recall
Electrosurgical pencil may remain activated or self activate after power switch is released.
FDA Determined
Cause 2
Device Design
Action Customers were notified by letter on March 25, 2010, and were instructed to return all affected devices and to forward the recall information to anyone that may have received the devices to the end user. More information is available by contacting the firm directly at 800-552-0138.
Quantity in Commerce 231,000 units (US), 12,250 units (Foreign)
Distribution Nationwide, including 2 VA facilities in GA and 1 military facility in UT. Foreign distribution to Australia, Belgium, Canada, China, Dominican Republic, El Salvador, Japan, Korea, Mexico, Puerto Rico, Saudi Arabia, Spain, Taiwan.
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.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = DAVOL, INC.
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