Events

Recall of Device Recall Total Contact Cast System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integra LifeSciences Corp..

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
    79636
  • Event Risk Class
    Class 2
  • Event Number
    Z-1487-2018
  • Event Initiated Date
    2017-08-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162863
  • 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
    Bandage, cast - Product Code ITG
  • Reason
    A quarantined lot of the devices was released for sale. devices from this lot may experience increased exothermic reaction causing higher levels of heat output which exceed the product specifications.
  • Action
    On 8/18/17, the recalling firm's sales reps notified affected consignees of the recall and distributed customer letters. Customers were asked to examine their inventory for product from the affected lot, warned not to use the product, complete the included "Acknowledgement and Return Form", and return the form by email or fax. Customers were provided with a Customer Service number: 1-800-654-2873.

Device

Device Recall Total Contact Cast System
  • Model / Serial
    Lot 1216033
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US nationwide distribution.
  • Product Description
    TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.