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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 pencilsee related information
Date Initiated by FirmMarch 29, 2010
Date PostedMay 10, 2010
Recall Status1 Terminated 3 on September 27, 2010
Recall NumberZ-1569-2010
Recall Event ID 55189
510(K)NumberK791137 
Product Classification Electrosurgical, cutting; coagulation & accessories - Product Code GEI
ProductConMed Goldline Hand Controlled with UltraClean Blade Electrode, Rocker Switch, Safety Holster and 10 FT Cable, REF 131307A, 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
ActionCustomers 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 Commerce32,640 units (US), 6,400 (Foreign)
DistributionNationwide, 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 CycleTPLC 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) Database510(K)s with Product Code = GEI
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