Events

Recall of Device Recall MAYFIELD Base Unit

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
    63776
  • Event Risk Class
    Class 2
  • Event Number
    Z-0558-2013
  • Event Initiated Date
    2012-11-05
  • Event Date Posted
    2012-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114754
  • 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
    Accessories, operating-room, table (kit) - Product Code FWZ
  • Reason
    An investigation of an adverse trend of complaints conducted by integra lifesciences identified various product performance issues which could impact the functionality of the firm's mayfield composite series base units and mayfield skull clamps. in order to prevent additional complaint reports, the firm decided to recall and replace certain lot codes of the base units and skull clamps that were d.
  • Action
    Integra issued an 'Urgent: Voluntary Medical Device Recall Notification with 'Recall Acknowledgment and Return Form' to all Integra Sales Representatives and Customers via visit and E-mail on November 5, 2012. The recall notice informs the customers of the firm's receipt of complaints pin-pointing quality issues with the MAYFIELD Base Units and MAYFIELD Skull Clamps which may impair their functionality. The customers are asked to sign and return the enclosed Recall Acknowledgement and Return Form so as to document their receipt of the recall notification and replacement products. The replacement products are to be delivered by the Integra NeuroSpecialist who is also responsible for returning the signed forms to Integra as documentation that the recalled devices have been replaced. Should the customer(s) have questions or concerns, they are directed to contact Integra Customer Service at: 1-877-444-1114,Option 3 for Technical Support.

Device

Device Recall MAYFIELD Base Unit
  • Model / Serial
    The recalle product is identified with the Lot Numbers: 097547 and 096546.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA TN, TX, UT, VA, WA and WI.
  • Product Description
    MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Base Unit, Model A3101. || The MAYFIELD Base Unit (A3101) is an operating room table accessory intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used. A Swivel Adaptor (A3018) is an integral component of the Base Unit A3101.
  • Manufacturer
    Integra LifeSciences Corporation

Manufacturer

Integra LifeSciences Corporation