Date Initiated by Firm |
December 18, 2008 |
Date Posted |
August 25, 2010 |
Recall Status1 |
Terminated 3 on October 22, 2010 |
Recall Number |
Z-2279-2010 |
Recall Event ID |
52030 |
510(K)Number |
K925903
|
Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
|
Product |
ABC PROBE REF 160656 5 mm Handswitching Probe, 28 cm QTY: 1 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13502 ASSEMBLED IN MEXICO
ABC PROBE REF 160656 5 mm Handswitching Probe, 28 cm QTY: 10 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13502 ASSEMBLED IN MEXICO
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/ Manufacturer |
ConMed Electrosurgery 14603 E Fremont Ave Centennial CO 80112-4251
|
For Additional Information Contact |
303-269-8824
|
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: 1656 cs (16560 units); Int'l: 1107 cs (11070 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 = BIRTCHER MEDICAL SYSTEMS, INC.
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