BEUDAMED
    FDA Recall Terminated

    Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Millennium Surgical, Boss Instruments, and Stealth Surgical brand names

    Recall: Z-0552-2015 · Initiated September 8, 2014

    Recall

    Recall Number
    Z-0552-2015
    Event Number
    69471
    Firm
    Instrumed International, Inc.
    FEI Number
    1421101
    Product Code
    HAX
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    September 8, 2014
    Posted
    December 16, 2014
    Terminated
    November 29, 2017
    Address
    626 Cooper Ct, Schaumburg, IL, 60173-4537

    Description

    Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Millennium Surgical, Boss Instruments, and Stealth Surgical brand names

    Reason

    The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.

    Action

    Instrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers. The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119.

    Distribution

    Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.

    Quantity

    49 lock nuts for titanium traction tongs