FDA Recall Terminated

ABC Bend-A-Beam Handpiece REF 134006 Handcontrol Malleable Handpiece, 6" (15.2 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, 6" (15.2 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.

Recall: Z-2277-2010 · Initiated December 18, 2008

Recall

Recall Number
Z-2277-2010
Event Number
52030
Firm
ConMed Electrosurgery
FEI Number
3004491689
Product Code
GEI
Status
Terminated
Root Cause
Process design
Initiated
December 18, 2008
Posted
August 25, 2010
Terminated
October 22, 2010
Address
14603 E Fremont Ave, Centennial, CO, 80112-4251

Description

ABC Bend-A-Beam Handpiece REF 134006 Handcontrol Malleable Handpiece, 6" (15.2 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, 6" (15.2 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.

Reason

The internal electrode protrudes in front of the ceramic insulator tip of the handpiece.

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.

Distribution

Nationwide and International

Quantity

Dom: 747 cs (7470 units); Int'l: 948 (9480 units)