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U.S. Department of Health and Human Services

Class 2 Device Recall ConMed Laparoscopic Instrument

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  Class 2 Device Recall ConMed Laparoscopic Instrument see related information
Date Initiated by Firm October 12, 2006
Date Posted October 27, 2006
Recall Status1 Terminated 3 on August 30, 2012
Recall Number Z-0114-2007
Recall Event ID 36515
510(K)Number K943327  
Product Classification Laparoscopic Instrument - Product Code GCJ
Product ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Dissector, 5mm x 43cm length, REF/Product Code 60-6040-434. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.
Code Information REF/Product Code 60-6040-434, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]
Recalling Firm/
Manufacturer		 Conmed Corporation
525 French Road
Utica NY 13502-5945
For Additional Information Contact Ms. Patricia Cotter
315-624-3533
Manufacturer Reason
for Recall		 The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 10/12/06, ConMed sent "URGENT DEVICE RECALL" packages (letter dated 10/11/06) to the domestic accounts via UPS Ground, and via UPS Express for the International accounts. Devices are to be removed from use and returned.
Quantity in Commerce 6 units
Distribution Worldwide
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 = GCJ and Original Applicant = CONMED CORP.
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