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U.S. Department of Health and Human Services

Class 2 Device Recall ConMed Detacha Tip

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  Class 2 Device Recall ConMed Detacha Tip see related information
Date Initiated by Firm March 27, 2006
Date Posted August 24, 2006
Recall Status1 Terminated 3 on April 27, 2012
Recall Number Z-1434-06
Recall Event ID 35949
510(K)Number K924283  
Product Classification Laparoscopic instrument - Product Code GEI
Product ConMed DetachaTip Multi-Use Laparoscopic Instrument, "Endoweave Multiple Use Grasper", 5 mm x 33 cm, REF/Product code 1-1028. -------- 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: 1-1028; all lot codes manufactured between 10/06/2003 and 2/14/2005. 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 3496 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 = GEI and Original Applicant = MICROSURGE, INC.
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