| Class 2 Device Recall Cambridge Endoscopic Autonomy LaparoAngle 5mm Metzenbaum Scissors with Monopolar Cautery | |
Date Initiated by Firm | May 20, 2011 |
Date Posted | July 06, 2011 |
Recall Status1 |
Terminated 3 on July 24, 2012 |
Recall Number | Z-2744-2011 |
Recall Event ID |
58919 |
510(K)Number | K061425 |
Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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Product | Cambridge Endoscopic Autonomy Laparo-Angle 5mm Metzenbaum Scissors with Monopolar Cautery, 45 cm
Catalog Number:
LA1101-12
Intended for use in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transection of tissue. |
Code Information |
Lot Numbers: CB036695, CB036727, CB036932, CB036708, CB036931 CB037433 |
Recalling Firm/ Manufacturer |
Cambridge Endoscopic Devices, Incorporated 119 Herbert Street Framingham MA 01702-8774
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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 | 255 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 |
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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.
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510(K) Database | 510(K)s with Product Code = GEI
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