BEUDAMED
    FDA Recall Terminated

    JUGGERKNOT INGUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the JuggerKnot 2.9mm Suture Anchor is to be placed. The JuggerKnot 2.9mm Suture Anchor is intended to be used to attach soft tissue to bone.

    Recall: Z-2399-2012 · Initiated August 14, 2012

    Recall

    Recall Number
    Z-2399-2012
    Event Number
    62391
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    LRY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 14, 2012
    Posted
    September 17, 2012
    Terminated
    April 18, 2013
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    JUGGERKNOT INGUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the JuggerKnot 2.9mm Suture Anchor is to be placed. The JuggerKnot 2.9mm Suture Anchor is intended to be used to attach soft tissue to bone.

    Reason

    Investigation found that the current design of the product allows the press-fit of the knob/shaft interface to be overcome by the impaction force of a mallet, causing the knob to potentially unfasten and slide down the shaft.

    Action

    Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated August 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Response Form was included for customers to complete and return via fax to 574-372-1683. Questions related to the recall should be directed to 574-371-3758, Monday through Friday, 8 a.m. to 5 p.m.

    Distribution

    Nationwide Distribution-including the states of WA, IN, AK, PA, GA, SD, KS, NY, VA, AR, AL, OH, WI, MA, and CA.

    Quantity

    62