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Class 2 Device Recall Electrosurgery Accessory Electrodes |
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Date Initiated by Firm |
November 02, 2007 |
Date Posted |
December 11, 2007 |
Recall Status1 |
Terminated 3 on March 31, 2010 |
Recall Number |
Z-0452-2008 |
Recall Event ID |
45867 |
510(K)Number |
K991855 K935091
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Product Classification |
Electrosurgery Accessory Electrodes - Product Code GEI
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Product |
Conmed Accessory Electrode, Universal Electrodes, Part/REF Numbers : 138100 through 138-105, 138107, 138110, 138112 and 138113, and Ultra Clean Accessory Electrode, Part/REF Numbers: 139100, 139107, 139108, 139321, 139112, 139104 EXT. 139105EXT, 139110EXT, and 139112EXT, Sterile, Rx Only, Conmed Corporation, Utica, New York 13502. |
Code Information |
Part Numbers: 138100, 138101, 138102, 138103, 138104, 138105, 138107, 138110, 138112, 138113, 139100, 139107, 139108, 139112, 139321, 139104EXT, 139105EXT, 139110EXT, 139112EXT. LOT CODES: 0706211 through 0709201. |
Recalling Firm/ Manufacturer |
ConMed Electrosurgery 14603 E. Fremont Avenue Centennial CO 80112
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For Additional Information Contact |
Shawn Riedel 303-269-8224
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Manufacturer Reason for Recall |
Sterility (package integrity) Compromised: packages of the electrosurgical blades and needles have an inadequate packaging seal
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FDA Determined Cause 2 |
Process design |
Action |
Consignees were notified by Urgent Voluntary Device Recall letter on 11/02/2007, from ConMed Corporation. They were asked to return affected product for replacement. |
Quantity in Commerce |
11,319 cases (476,160 units) |
Distribution |
Worldwide: USA and countries of Australia, Canada, China, Belgium, Chile, Denmark, Ecuador, France, Greece, India, Israel, Italy, Japan, Korea, Mexico, New Zealand, Norway, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Thailand, Trinidad, and Uruguay. |
Total Product Life Cycle |
TPLC Device Report
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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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510(K) Database |
510(K)s with Product Code = GEI and Original Applicant = CONMED CORP.
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