Events

Recall of Device Recall MAYFIELD Horseshoe Gel Pads Left Gel Pad

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

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
    62711
  • Event Risk Class
    Class 2
  • Event Number
    Z-2457-2012
  • Event Initiated Date
    2012-07-27
  • Event Date Posted
    2012-09-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111476
  • 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 customer complaints identified that for two product lots, left horseshoe gel pads were packaged as a right horseshoe gel pads and vice versa. none of the complaints resulted in a report of patient injuries or an increase in the time to complete the surgical procedure. a physician was consulted to assess patient risk and concluded that there is no potential harm to patients, onl.
  • Action
    Integra Lifesciences sent an "URGENTURGENT: VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" letter dated July 27, 2012 to all affected customers. The letter identifies the affected products, problem and actions to be taken by the customers. Customers were instructed to check their inventory for affected products and quarantine them for shipment back to Integra. Customers were asked to complete the Recall Acknowledgement and Return Forms ASAP whether or not they intended on returning any recalled product. Contact Integra Customer Service at 1-877-444-1114, Option 3 for Technical Support.

Device

Device Recall MAYFIELD Horseshoe Gel Pads Left Gel Pad
  • Model / Serial
    The Lot No's for the affected Gel Pads are Lot 093990 of part number #440C1012 for Left Gel Pads
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide including the states of AZ, CA, CO, DC, GA, IA, IL, IN, NC, and NY and the countries of: Canada and Belgium.
  • Product Description
    The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. || The Gel Pads are supplied to users in labeled plastic bags, 1 per bag. || Product Usage: || The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. They are plastic gel filled devices that provide cushioning between the head and other metallic part of the MAYFIELD¿ system. The Left and Right Pads are mirror images.
  • Manufacturer
    Integra Limited

Manufacturer

Integra Limited
  • Manufacturer Address
    Integra Limited, 311 Enterprise Dr, Plainsboro NJ 08536-3344
  • Source
    USFDA