Date Initiated by Firm |
March 27, 2006 |
Date Posted |
August 24, 2006 |
Recall Status1 |
Terminated 3 on April 27, 2012 |
Recall Number |
Z-1433-06 |
Recall Event ID |
35949 |
510(K)Number |
K924283
|
Product Classification |
Laparoscopic instrument - Product Code GEI
|
Product |
ConMed DetachaTip Multi-Use Laparoscopic Instrument - "Fenestrated (Duckbill) Multiple Use Grasper", 5 mm x 33 cm, REF/Product code-1-1008. ------- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility. |
Code Information |
Product Code: 1-1008; all lot codes manufactured between 10/20/2003 and 2/16/2005. Each lot code is found on the package labeling of unopened units and is also embossed on the grey hub of the device. For 5 digit lot codes: the 1st digit represents the year (4 represents 2004), the 2nd & 3rd digits represent the month (09 for September), and the 4th & 5th digits for the day of the month. For 7 digit lot codes: the 1st two digits represent the year, the 3rd & 4th represent the month, the 5th & 6th represent the day of the month, and the 7th digit represents the manufacturing shift code. |
Recalling Firm/ Manufacturer |
Conmed Corporation 525 French Rd Utica NY 13502-5945
|
For Additional Information Contact |
Ms. Nancy Crisino 800-765-8375 Ext. 3059
|
Manufacturer Reason for Recall |
Grasper jaws breaking at the junction of the jaw and tube during laparoscopic procedures.
|
FDA Determined Cause 2 |
Other |
Action |
On 3/27/06, all domestic customers were sent an "URGENT DEVICE RECALL" notice, dated 3/27/06, by USPS Priority Mail (Delivery Confirmation). International customers were notified by facsimile and/or e-mail as well as by mail. |
Quantity in Commerce |
5205 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 = GEI and Original Applicant = MICROSURGE, INC.
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