Events

Recall of Integra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm) , Sterile

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
    48964
  • Event Risk Class
    Class 3
  • Event Number
    Z-2328-2008
  • Event Initiated Date
    2008-07-02
  • Event Date Posted
    2008-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72417
  • 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
    Device, Dermal Replacement - Product Code MDD
  • Reason
    Product labeled with an expiration date on may 2010, while the actual expiration date should be april 2010.
  • Action
    The firm issued a letter titled URGENT-RECALL NOTICE to Integra Sales Reps on July 2, 2008. Contact Integra at 609-799-3297 if you have questions.

Device

Integra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm) , Sterile
  • Model / Serial
    Catalog Number 38101, Lot Number 105BA0121823
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Product was distributed to 5 hospitals in TN, CA, NY, IN and AL.
  • Product Description
    Integra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm) , Sterile; || Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536 USA
  • Manufacturer
    Integra LifeSciences Corp

Manufacturer

Integra LifeSciences Corp