Recall Z-3067-2011 ยท GCJ Laparoscope, General & Plastic Surgery
Applied Medical Resources Corp
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 en
| Date | Aug 24, 2011 (initiated Dec 18, 2009) |
| Status | Terminated |
| 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. |
| Root cause | 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 |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060096 | MODULAR TROCAR SYSTEM Applied Medical Resources Corp., Jan 24, 2006 |