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U.S. Department of Health and Human Services

Class 2 Device Recall Applied Medical Kii Optical Access System

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  Class 2 Device Recall Applied Medical Kii Optical Access System see related information
Date Initiated by Firm December 18, 2009
Date Posted August 24, 2011
Recall Status1 Terminated 3 on September 06, 2011
Recall Number Z-3069-2011
Recall Event ID 59560
510(K)Number K060096  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
Product Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R39


Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indicated for use in general, abdominal, gynecological and thoraic minimally invasive surgeries. Trocars establish a path of entry through tissue planes and into internal spaces for purposes of inserting endoscopic instruments that are used to perform surgery on internal organs.
Code Information 1084821, 1084822, 1084823, 1089653, 1090833, 1096177
Recalling Firm/
Manufacturer		 Applied Medical Resources Corp
22872 Avenida Empresa # 3
Rancho Santa Margarita CA 92688-2650
For Additional Information Contact
949-713-8000
Manufacturer Reason
for Recall		 The recall was expanded on December 22, 2009 to include four models: C0R36, C0R37, C0R38, and C0R39. Initially, Applied Medical conducted a voluntary recall on June 9, 2009 of two lot numbers, 1084426 and 1085506, of the 15 mm Kii non-threaded optical access system, model C0R36, due to a potential weakness in the cannula tip, possibly resulting in a tip breakage.
FDA Determined
Cause 2		 Component design/selection
Action Applied Medical Resources Corp. notified customers via an overnight "URGENT: MEDICAL DEVICE RECALL" letter dated December 22, 2009. The letter informed customers of the recalled products, problem, and actions to be taken. The letter asked that the listed recalled products be returned immediately. The customers were asked to check their inventory, complete the attached Voluntary Recall Notification Confirmation Form and fax as per the instructions. The recall letter provided customers with a contact and telephone number for product return questions (1-949-713-8652) and a separate contact for regulatory questions (1-949-713-8369).
Quantity in Commerce 13,791 units total
Distribution Worldwide Distribution - Nationwide in the USA and to countries of: Australia, Austria, Belgium, Canada, Chile, Columbia, Cyprus, Denmark, Finland, France, Germany, Great Britain, Hong Kong, India, Ireland, Italy, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, South Africa, and Switzerland.
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 = GCJ and Original Applicant = APPLIED MEDICAL RESOURCES CORP.
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