Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ConMed Laparoscopic Instrument

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall ConMed Laparoscopic Instrumentsee related information
Date Initiated by FirmOctober 12, 2006
Date PostedOctober 27, 2006
Recall Status1 Terminated 3 on August 30, 2012
Recall NumberZ-0095-2007
Recall Event ID 36515
510(K)NumberK943327 
Product Classification Laparoscopic Instrument - Product Code GCJ
ProductConMed Laparoscopic Instrument: Babcock Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6047-001. --- 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 60-6047-001, 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 ContactMs. 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
ActionOn 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 Commerce287 units
DistributionWorldwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GCJ
-
-