Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cambridge Endoscopic Devices, Incorporated.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58919
  • Event Risk Class
    Class 2
  • Event Number
    Z-2743-2011
  • Event Initiated Date
    2011-05-20
  • Event Date Posted
    2011-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100610
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Reason
    Pet shrink sleeve insulation material dislodging from the distal tips of autonomy laparo-angle (ala) metzenbaum scissors.
  • 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.

Device

Device Recall Cambridge Endoscopic Autonomy LaparoAngle 5mm Metzenbaum Scissors with Monopolar C...
  • Model / Serial
    Lot Numbers: CB036637, CB036683, CB036731, CB036778, CB036817 CB036903, CB036909, CB036977, CB037009, CB037057 CB037093, CB037114, CB037292, CB037382,
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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.
  • Manufacturer
    Cambridge Endoscopic Devices, Incorporated

Manufacturer

Cambridge Endoscopic Devices, Incorporated
  • Manufacturer Address
    Cambridge Endoscopic Devices, Incorporated, 119 Herbert Street, Framingham MA 01702-8774
  • Manufacturer Parent Company (2017)
    Cambridge Endoscopic Devices Inc.
  • Source
    USFDA