Z-0644-2013Class II

Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally...

Name: Z-0644-2013 Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally...
Creator: Applied Medical Resources Corp
Published: 2012-11-05
License: https://open.fda.gov/license/

Applied Medical Resources Corp / initiated 2012-11-05 / Terminated / root cause: manufacturing process

FDA source

Applied Medical Resources Corp began a recall of Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of... on 2012-11-05. FDA classified it as Class II and gives the reason as "Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the blade to remain exposed after shield deployment. Further...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0644-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-05
Posted: 2013-01-07
Terminated: 2013-01-16
Recalling firm: Applied Medical Resources Corp
Product: Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
Product code: CGJ Radioimmunoassay, Follicle-Stimulating Hormone
Reason for recall: Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the blade to remain exposed after shield deployment. Further use of any affected product should cease immediately. The affected model number is CTB71, and the affected lot is 1179107.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Applied Medical sent an Urgent Medical Device Recall to all affected customers in November 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product, complete the attached Recall Notification Confirmation Form to acknowledge the recall and indcated any product their facility is returning. The Recall confirmation form should be returned to Applied Medical by emailing to recall60494844#applied medical.com or fax to 949-713-8832. Return affecte4d product and a copy of the confirmation form to Applied Medical. Customers with questions were instructed to call 949-713-8662. For questions regarding this recall 949-713-8662.
Quantity in commerce: 72 units
Distribution: Worldwide Distribution - USA (nationwide) and France.
Product codes and lots: Lot Number: 1179107

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0644-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0644-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-07

Product code CGJ

K072674Class IIKii Trocar SystemApplied Medical Resources Corp. / cleared 2007-10-05

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)