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U.S. Department of Health and Human Services

Class 2 Device Recall ABC BendABEAM Handpiece,134009

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  Class 2 Device Recall ABC BendABEAM Handpiece,134009 see related information
Date Initiated by Firm December 18, 2008
Date Posted August 25, 2010
Recall Status1 Terminated 3 on October 22, 2010
Recall Number Z-2278-2010
Recall Event ID 52030
510(K)Number K961505  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product ABC Bend-A-Beam Handpiece REF 134009 Handcontrol Malleable Handpiece, 9" (22.8 cm) QTY: 1 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO (Pouch label)

ABC Bend-A-Beam Handpiece REF 134006 Handcontrol Malleable Handpiece, 9" (22.8 cm) QTY: 10 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO (Case label)

Usage: Electrosurgical handpiece for use as monopolar electrosurgical accessory in conjunction with CONMED electrosurgical units equipped with argon beam coagulation.
Code Information Lot: 0306021 through 0806021
Recalling Firm/
ConMed Electrosurgery
14603 E Fremont Ave
Centennial CO 80112-4251
For Additional Information Contact
Manufacturer Reason
for Recall
The internal electrode can protrude in front of ceramic insulator at the tip of the ABC Handpiece used with Conmed Electrosurgical units.
FDA Determined
Cause 2
Process design
Action An Urgent Device Recall notification was issued 12/18/2008, which explained the problem/risk associated with the device, the discontinuance of use and the return of the device. If you have any questions, please contact 800-552-0138, ext. 5225.
Quantity in Commerce Dom: 233 cs (2330 units); Int'l: 275 cs (2750 units)
Distribution Nationwide and International
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 = CONMED CORP.