Events

Recall of Device Recall DURAGEN II DURAL REGENERATION MATRIX

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
    54253
  • Event Risk Class
    Class 2
  • Event Number
    Z-1081-2010
  • Event Initiated Date
    2010-01-13
  • Event Date Posted
    2010-03-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87963
  • 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
    One lot of suturable duragen dural regeneration matrix (# 1091575) did not pass stability testing at certain time points for suture retention strength and shrink temperature specifications.
  • Action
    An "URGENT PRODUCT RECALL NOTIFICATION" dated January 13, 2010, was sent via Federal Express to customers. The notification described the product, problem, hazard involved and action to be taken by customers. In the event that the customers have in their possession any products from the specific lot number 1091576, the customers are being ask to please immediately quarantine all stock on hand and contact their local Integra Sales representative for further assistance and for arrangements of product return. The customers are being ask to return the enclosed "Recall Acknowledge and Return Form" indicating whether or not they possess any of the affected product identified. Integra will replace any product affected by this Recall that is returned. Please feel free to contact me at 609-936-5407 should you have any additional questions.

Device

Device Recall DURAGEN II DURAL REGENERATION MATRIX
  • Model / Serial
    Catalog Number DURS3391; Lot number 1091575
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution:Ca, NY, TX, CO, VA, SC, IA, MO, IL, LA, OR, OH, WI, FL, DC, DE, MD, MN.
  • Product Description
    Suturable DuraGen Dural Regeneration Matrix; || Non-Pyrogenic; || Sterility guaranteed unless package is damaged or opened. Rx only. || Manufacturer: Integra LifeSciences Corporation, Plainsboro, NJ 08536 || Suturable DuraGen is an absorbable implant for repair of dural defects. It is indicated as a dural substitute for the repair of dura matter.
  • Manufacturer
    Integra LifeSciences Corp

Manufacturer

Integra LifeSciences Corp