Events

Recall of Device Recall Integra LifeSciences Corp.

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
    76408
  • Event Risk Class
    Class 3
  • Event Number
    Z-1410-2017
  • Event Initiated Date
    2017-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153110
  • 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
    Staple, fixation, bone - Product Code JDR
  • Reason
    The firm received one complaint from one non-us sales representative (france) that the label on the uni-cp plate was incorrect.
  • Action
    Integra LifeSciences Corp. issued a recall letter/return response form on 1/25/2017.

Device

Device Recall Integra LifeSciences Corp.
  • Model / Serial
    Lot # FEDT
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    The UNI-CP System; Model Number: 330230SND.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.