BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2457-2012 · Initiated July 27, 2012

    Recall

    Recall Number
    Z-2457-2012
    Event Number
    62711
    Firm
    Integra Limited
    FEI Number
    3001700044
    Product Code
    FWZ
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    July 27, 2012
    Posted
    September 26, 2012
    Terminated
    February 20, 2013
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    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.

    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.

    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.

    Quantity

    11 from Lot 0938990