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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-0096-2007
Recall Event ID 36515
510(K)Number K943327  
Product Classification Laparoscopic Instrument - Product Code GEJ
Product ConMed Laparoscopic Instrument: Babcock Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6047-431. --- 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 60-6047-431, 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/
Conmed Corporation
525 French Road
Utica NY 13502-5945
For Additional Information Contact Ms. Patricia Cotter
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 32 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 = GEJ and Original Applicant = CONMED CORP.