Events

Recall of Device Recall EnDura

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Shelhigh 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
    28148
  • Event Risk Class
    Class 2
  • Event Number
    Z-0588-04
  • Event Initiated Date
    2003-12-19
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-04-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31275
  • 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
    Dura Substitute - Product Code GXQ
  • Reason
    The tamper-evident shrink band may fall off causing the user uncertainty whether the product was opened and is still sterile.
  • Action
    Letter was sent 12/19/2003 to the 19 hospitals were the product was distributed.

Device

Device Recall EnDura
  • Model / Serial
    Lot#, Catalog #, Description:  030911-NR, ENR-20210, 2CM X 10CM; 030911-NR, ENR-20404, 4CM X 4CM; 030911-NR, ENR-20506, 5CM X 6CM; 030808-NR, ENR-20610, 6CM X 10CM; 030811-NR, ENR-20610, 6CM X 10CM; 030911-NR, ENR-21012, 10CM X 12CM; 030924-NR, ENR-21012, 10CM X 12CM; 031027-NR, ENR-21212, 12CM Diameter.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The product is distributed natiowide to 19 different hospitals.
  • Product Description
    EnDura No-React Dural Substitute. Product comes in different sizes (2x10, 4x4, 5x6, 6x10, 10x12, and 12 cm diameters), sterile, stored in 2% benzyl alcohol, and distributed by Integra NeuroSciences, Plainsboro, NJ 08536.
  • Manufacturer
    Shelhigh Inc

Manufacturer

Shelhigh Inc
  • Manufacturer Address
    Shelhigh Inc, 650 Liberty Ave, Union NJ 07083-8130
  • Source
    USFDA