Events

Recall of Device Recall Fiber Stripper

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by American Medical Systems Innovation Center - Silicon Valley.

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
    71534
  • Event Risk Class
    Class 2
  • Event Number
    Z-2165-2015
  • Event Initiated Date
    2015-05-28
  • Event Date Posted
    2015-07-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138133
  • 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
    Powered laser surgical instrument - Product Code GEX
  • Reason
    Validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (ifu) for the sure flex'" reusable fibers and the reusable stripper and cleaver accessories do not meet the new guidance on qualifying reusable products.
  • Action
    Urgent Medical Device Field notification letters were sent on June 9, 2015. Translation for countries out of the US will be conducted. Communications are being coordinated by the Prostate Health QA Director. Urgent Medical Device Field notification Letters advised customers of the issue and list all affected products with name and model numbers. Any SureFlex Reuseable Fibers which have not been used but are in inventory and with the 3 year shelf life should be returned as per instructions enclosed. Any of the SureFlex devices in inventory that have been used should be discarded or returned. All Reuseable Stripper and Cleaver Accessories that have not been used should be returned. Used devices should be destroyed or returned. Questions to 1-408-456-3320. The Acknowledgement form should be completed and returned.

Device

Device Recall Fiber Stripper
  • Model / Serial
    Model 80-10001-003; All product manufactured from April 8, 2012 to April 8, 2015
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the countries of: Argentina France Morocco, South Africa, Australia, Germany, Netherlands, Spain, Austria, Greece, New Zealand, Sri Lanka, Belgium, Guatemala, Norway, Switzerland, Bolivia, India, Panama, Thailand, Brazil, Ireland, Peru, Turkey, Canada, Israel, Poland, United Kingdom, Chile, Italy, Portugal, United States, Colombia, Korea, Qatar, Uruguay, Costa Rica, Lebanon, Romania, Finland, Malaysia and Saudi Arabia.
  • Product Description
    Fiber Stripper, 200¿m, Autoclavable; || The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size.
  • Manufacturer
    American Medical Systems Innovation Center - Silicon Valley

Manufacturer

American Medical Systems Innovation Center - Silicon Valley
  • Manufacturer Address
    American Medical Systems Innovation Center - Silicon Valley, 3070 Orchard Dr, San Jose CA 95134-2011
  • Source
    USFDA