Date Initiated by Firm |
October 12, 2006 |
Date Posted |
October 27, 2006 |
Recall Status1 |
Terminated 3 on August 30, 2012 |
Recall Number |
Z-0103-2007 |
Recall Event ID |
36515 |
510(K)Number |
K943327
|
Product Classification |
Laparoscopic Instrument - Product Code GCJ
|
Product |
ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-004. --- 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 60-6045-004, 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 company was made aware of instances where the grasper jaws broke during laparoscopic procedures. When the grasper jaws had broken they had done so at the junction of the jaw and the tube. In no instances was it reported to the company that small pieces had broken off of the grasper jaws.
|
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 |
38 units |
Distribution |
Worldwide |
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.
|
510(K) Database |
510(K)s with Product Code = GCJ and Original Applicant = CONMED CORP.
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