BEUDAMED
    FDA Recall Terminated

    REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.

    Recall: Z-2362-2012 · Initiated January 24, 2012

    Recall

    Recall Number
    Z-2362-2012
    Event Number
    62140
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    HTW
    Status
    Terminated
    Root Cause
    Finished device change control
    Initiated
    January 24, 2012
    Posted
    September 11, 2012
    Terminated
    September 26, 2012
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    Description

    REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.

    Reason

    Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.

    Action

    The firm, Exactech, Inc., called the lone customer on January 24, 2012 to discuss the product, problem and actions to be taken. The customer was instructed to return all unused devices and associated packaging.

    Distribution

    Nationwide distribution: USA state of: Arkansas only

    Quantity

    2