Z-3067-2011

Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R37

Name: Z-3067-2011 Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R37
Creator: Applied Medical Resources Corp
Published: 2009-12-18
License: https://open.fda.gov/license/

Applied Medical Resources Corp / initiated 2009-12-18 / Terminated / root cause: design

FDA source

Applied Medical Resources Corp began a recall of 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... on 2009-12-18. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3067-2011
Status: Terminated
Initiated: 2009-12-18
Posted: 2011-08-24
Terminated: 2011-09-06
Recalling firm: Applied Medical Resources Corp
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.
Product code: GCJ Laparoscope, General & Plastic Surgery
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.
Root cause tag: design
FDA 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 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.
Product codes and lots: 1077612, 1078134, 1079448, 1081556, 1082011, 1083371, 1084938, 1085509, 1087279, 1089638, 1088096, 1090841, 1091538, 1093144, 1097420

Product code GCJ

K060096Class IIModular Trocar SystemApplied Medical Resources Corp. / cleared 2006-01-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)