| Class 2 Device Recall Applied Medical Kii Optical Access System | |
Date Initiated by Firm | December 18, 2009 |
Date Posted | August 24, 2011 |
Recall Status1 |
Terminated 3 on September 06, 2011 |
Recall Number | Z-3068-2011 |
Recall Event ID |
59560 |
510(K)Number | K060096 |
Product Classification |
Laparoscope, general & plastic surgery - Product Code GCJ
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Product | Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R38
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 |
1084813, 1084814, 1084820, 1089654, 1091175, 1090426 |
Recalling Firm/ Manufacturer |
Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa Margarita CA 92688-2650
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = GCJ
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