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U.S. Department of Health and Human Services

Class 2 Device Recall Cambridge Endoscopic Autonomy LaparoAngle 5mm Metzenbaum Scissors with Monopolar Cautery

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  Class 2 Device Recall Cambridge Endoscopic Autonomy LaparoAngle 5mm Metzenbaum Scissors with Monopolar Cautery see related information
Date Initiated by Firm May 20, 2011
Date Posted July 06, 2011
Recall Status1 Terminated 3 on July 24, 2012
Recall Number Z-2743-2011
Recall Event ID 58919
510(K)Number K061425  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Cambridge Endoscopic Autonomy Laparo-Angle 5mm Metzenbaum Scissors with Monopolar Cautery, 34cm
Catalog Number:
LA1101-01

Intended for use in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transection of tissue.
Code Information Lot Numbers: CB036637, CB036683, CB036731, CB036778, CB036817 CB036903, CB036909, CB036977, CB037009, CB037057 CB037093, CB037114, CB037292, CB037382,
Recalling Firm/
Manufacturer		 Cambridge Endoscopic Devices, Incorporated
119 Herbert Street
Framingham MA 01702-8774
For Additional Information Contact
508-405-7090
Manufacturer Reason
for Recall		 PET shrink sleeve insulation material dislodging from the distal tips of Autonomy Laparo-Angle (ALA) Metzenbaum Scissors
FDA Determined
Cause 2		 Process control
Action Cambridge Endoscopic Devices, Inc. sent an "IMPORTANT MEDICAL DEVICE RECALL" letter dated May 20, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers are instructed to return unused inventory using RGA Number 301. Returned devices will be replaced. Questions regarding this recall, call 508-405-0790 for assistance.
Quantity in Commerce 647 units
Distribution Worldwide Distribution--USA (nationwide) and the countries of Armenia , Australia, Austria, Chile, China, Denmark, Hong Kong, India, Ireland , Italy, Japan, Saudi Arabia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = CAMBRIDGE ENDOSCOPIC DEVICES
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