Events

Recall of Device Recall Integra Cranial Access Kits

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

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
    75028
  • Event Risk Class
    Class 2
  • Event Number
    Z-2733-2016
  • Event Initiated Date
    2016-08-24
  • Event Date Posted
    2016-09-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149138
  • 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
    Drills, burrs, trephines & accessories (manual) - Product Code HBG
  • Reason
    Integra lifesciences has been notified of a medical device recall by adaptive surgical, llc involving their riverlon" nylon 3-0 sutures that are packaged in integras cranial access kits. it was found that product seals may become open during extreme distribution conditions and render the device unsterile.
  • Action
    Consignees notified on August 12, 2016 via letter to identify and return product.

Device

Device Recall Integra Cranial Access Kits
  • Model / Serial
    Lot W1605101: Exp 2016-12 Lot W1605103: Exp 2016-11 Lot W1605106: Exp 2016-11 Lot W1606063: Exp 2016-12 Lot W1605101: Exp 2016-12 W1605103: 2016-11 W1605106: 2016-11 W1606063: 2016-12
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and VA/govt/military. No foreign consignees.
  • Product Description
    Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
  • Manufacturer
    Integra LifeSciences Corp. d.b.a. Integra Pain Management

Manufacturer

Integra LifeSciences Corp. d.b.a. Integra Pain Management
  • Manufacturer Address
    Integra LifeSciences Corp. d.b.a. Integra Pain Management, 3498 W 2400 S Ste 1050, Salt Lake City UT 84119-1135
  • Manufacturer Parent Company (2017)
    Integra LifeSciences Holdings Corporation
  • Source
    USFDA