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U.S. Department of Health and Human Services

Class 3 Device Recall Electrode hand piece, foot activiated

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  Class 3 Device Recall Electrode hand piece, foot activiated see related information
Date Initiated by Firm September 06, 2012
Date Posted October 03, 2012
Recall Status1 Terminated 3 on October 22, 2012
Recall Number Z-0008-2013
Recall Event ID 63253
510(K)Number K0404780  
Product Classification Electrocautery, gynecologic (and accessories) - Product Code HGI
Product Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activated*** Manufactured for GYNEX***"

Gynex catalog number: 950 (Gynex REF 950, Electrode Handpiece)

It connects the electrode to the food activated electric generator. Electrodes are used in gynecological procedures, in a physician's office, for cutting to remove tissue and coagulation to control bleeding by the use of high frequency current.
Code Information Manufacturer's lot number: 54-12-2-21-12. 
Recalling Firm/
Manufacturer		 Gynex Corporation
14603 NE 87th St.
Redmond WA 98052
For Additional Information Contact Karen L Cardiff
425-882-1179
Manufacturer Reason
for Recall		 The wrong electrical connector pin was attached to the cord during assembly by the manufacturer. this electrical connector is too big to fit into the port on the foot activated generator. this makes the device unusable.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were first notified by phone with a follow up e-mail or fax. The consignees were asked to complete the response section regarding the destruction/return of the device. For questions regarding this recall call 425-882-1179.
Quantity in Commerce 19 boxes (containing 12 electorde hand pieces each)
Distribution Nationwide 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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