FDA · Medical device recall

Applied Medical 15x100 mm Kii Optical Access Systems… and 3 more products

Aug. 24, 2011

Date posted by the FDA: Aug. 24, 2011
Status: Terminated
Filed by: Applied Medical Resources Corp
Reason: 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.
Distribution pattern: 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.

4 products in this recall

Applied Medical 15x100 mm Kii Optical Access Systems…

Product: Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R36 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.
Quantity: 13,791 units total
Codes and lots: 1077611, 1078133, 1079447, 1080157, 1080435, 1082010, 1084042, 1087280, 1087831, 1088565, 1089637, 1089939, 1089988, 1090427, 1091067, 1090849, 1091176, 1092599
Recall started: Dec. 18, 2009
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Component design/selection
What the company told customers: 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).
Recall number: Z-3066-2011

Applied Medical 15x100 mm Kii Optical Access Systems…

Product: Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R37 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.
Quantity: 13,791 units total
Codes and lots: 1077612, 1078134, 1079448, 1081556, 1082011, 1083371, 1084938, 1085509, 1087279, 1089638, 1088096, 1090841, 1091538, 1093144, 1097420
Recall started: Dec. 18, 2009
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Component design/selection
What the company told customers: 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).
Recall number: Z-3067-2011

Applied Medical 15x100 mm Kii Optical Access Systems…

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.
Quantity: 13,791 units total
Codes and lots: 1084813, 1084814, 1084820, 1089654, 1091175, 1090426
Recall started: Dec. 18, 2009
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Component design/selection
What the company told customers: 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).
Recall number: Z-3068-2011

Applied Medical 15x100 mm Kii Optical Access Systems…

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.
Quantity: 13,791 units total
Codes and lots: 1084821, 1084822, 1084823, 1089653, 1090833, 1096177
Recall started: Dec. 18, 2009
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Component design/selection
What the company told customers: 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).
Recall number: Z-3069-2011

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-3066-2011, Z-3067-2011, Z-3068-2011, Z-3069-2011. The agency record governs; check it and the company before acting.

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