Events

Recall of Device Recall TLC Self Retaining Retractor System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Applied Medical Technology Inc.

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
    73318
  • Event Risk Class
    Class 2
  • Event Number
    Z-1608-2016
  • Event Initiated Date
    2016-02-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143863
  • 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
    Retractor - Product Code GAD
  • Reason
    The firm received a complaint of an open pouch which breaches the sterilization validation.
  • Action
    AMT sent an Urgent Medical Device Recall letter dated February 17, 2016 to their customers. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Service at 440-717-4000.

Device

Device Recall TLC Self Retaining Retractor System
  • Model / Serial
    Part #: M0068201750;   Part #: M0068201761;
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was shipped to the following states: AL, AR, AZ, CA, CT, FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, OH, PA, SC, TN,TX, UT, VA & WI. Product was also shipped to the following countries: Austria, Denmark, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland & United Kingdom.
  • Product Description
    TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY || Product Usage: || Indicated to aid in tissue retraction during a surgical procedure.
  • Manufacturer
    Applied Medical Technology Inc

Manufacturer

Applied Medical Technology Inc
  • Manufacturer Address
    Applied Medical Technology Inc, 8000 Katherine Blvd, Brecksville OH 44141-4202
  • Manufacturer Parent Company (2017)
    Applied Medical Technology Inc.
  • Source
    USFDA