Applied Medical 15x100mm Kii Optical Access System, Non-Threaded 6/Box, Model Number: C0R36, Labeled Sterile. Disposable single-use devices indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgeries. Endoscopic instruments for surgery.
FDA Recall Z-2226-2009 · Posted 2009-09-18
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Recalling FirmApplied Medical Resources Corp
Recall StatusTerminated
Product CodeGCJ
Date Initiated2009-06-04
Date Terminated2011-07-14
Product Quantity934 units
Reason for Recall
Applied Medical is conducting a coluntary recall of two lot numbers, 1084426 and 1085506, of the 15mm Kii non-threaded optical access system, model C0R36, due to a potential weakness in the cannula tip, possibly resulting in tip breakage.
Firm Action
Applied Medical Resources Corp. notified Customers via an overnight "Voluntary Recall Notification" Letter dated June 9, 2009. The letter informed customers of the reason for recall and asked that the listed product be returned. 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).
Root Cause
Component design/selection
Distribution Pattern
Class II Recall - Worldwide -- United States, Australia, New Zealand, France, Canada, Norway and Great Britain.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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