Events

Recall of Device Recall MAYFIELD

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

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
    29495
  • Event Risk Class
    Class 2
  • Event Number
    Z-1221-04
  • Event Initiated Date
    2004-06-29
  • Event Date Posted
    2004-07-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-11-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33840
  • 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
    Holder, Head, Neurosurgical (Skull Clamp) - Product Code HBL
  • Reason
    Skull pins, which fractured below device specifications during qc testing, were distributed.
  • Action
    The firm notified their customers of the recall via facsimile on 6/29/2004. The faxed notification was followed by a hard copy of the recall letter sent via overnight mail. The letter instructs the customers to immediate cease using of the affected product; complete the Fax Back form provided with the recall notice; and return the affected product to Integra for replacement.

Device

Device Recall MAYFIELD
  • Model / Serial
    Lot Code: #42358
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed to the following states: NY, TX, MD, CO
  • Product Description
    MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020
  • Manufacturer
    Integra LifeSciences Corporation

Manufacturer

Integra LifeSciences Corporation
  • Manufacturer Address
    Integra LifeSciences Corporation, 4900 Charlemar Drive, Cincinnati OH 45227
  • Source
    USFDA