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U.S. Department of Health and Human Services

Class 2 Device Recall Integra(TM) Jarit(R) TakeApart Endoscopic Instruments

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 Class 2 Device Recall Integra(TM) Jarit(R) TakeApart Endoscopic Instrumentssee related information
Date Initiated by FirmMay 23, 2012
Date PostedJuly 18, 2012
Recall Status1 Terminated 3 on March 19, 2013
Recall NumberZ-2028-2012
Recall Event ID 62464
510(K)NumberK103726 
Product Classification Coagulator-cutter, endoscopic, unipolar (and accessories) - Product Code KNF
ProductIntegra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecological surgery and other operative procedures under endoscopic observations. For use when a rigid endoscopic instrument for grasping, dissecting and/or other manipulation of soft tissue is determined to be appropriate by the surgeon.
Code Information Model number 643350 -- batch numbers 1045878, 1045879, 1045881, 1045880, 1045872, 1045882, 1045876, 1045877, 1045873, 1045874, and 1045875. Model number 643425 -- batch numbers 1045890, 1045886, 1045884, 1045887, 1045888, 1045889, and 1045885. Model number 643650 -- batch numbers 1045891, 1045892, and 1045893. Model number 643725 -- batch numbers 1045894 and 1045895.  
FEI Number 3001700044
Recalling Firm/
Manufacturer		 Integra Limited
311 Enterprise Dr
Plainsboro NJ 08536-3344
Manufacturer Reason
for Recall		The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionIntegra sent a Urgent Field Corrective Action letter dated May 23, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed customers and sales reps to return the instruments identified on the attached part number list and complete a "Field Corrective Action Acknowledgement and Return Form" to be completed and returned to the firm. We apologize for any inconvenience this issue may cause you. Please call Integra Surgical Customer Service at 800-431-1123 if you have any questions.
Quantity in Commerce108
DistributionUSA (nationwide) including the states of AZ, CA, IL, MA, MN, NJ, OK, TN, TX, VA, WA and WI.
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 = KNF
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