BEUDAMED
    FDA Recall Terminated

    I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill during IM Hole preparation. The instrument is positioned between the condyles and aligned with the anatomical axis. Pins can be placed in the IM hole locator to assist with additional stability. The drill bush may also be lightly impacted onto the distal femur for additional stability.

    Recall: Z-0908-2015 · Initiated November 12, 2014

    Recall

    Recall Number
    Z-0908-2015
    Event Number
    70046
    Firm
    DePuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 12, 2014
    Posted
    January 5, 2015
    Terminated
    February 24, 2015
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill during IM Hole preparation. The instrument is positioned between the condyles and aligned with the anatomical axis. Pins can be placed in the IM hole locator to assist with additional stability. The drill bush may also be lightly impacted onto the distal femur for additional stability.

    Reason

    Use of excessive force when impacting may lead to intra-operative femoral fracture.

    Action

    The firm, DePuy Synthes, sent an "URGENT INFORMATION - DEVICE CORRECTION NOTICE HP LCS IM Hole Locator" notification dated November 12, 2014 to the affected distributors. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The distributors were instructed to: review the instructions and the information in this notice; provide this notice to your sales consultants, and complete and return the DISTRIBUTOR RESPONSE CARD: Verify Sales Consultant Notifications via fax to (574) 371-4939 or email: [email protected]. For questions, please contact Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. - 5 p.m. EST).

    Distribution

    Worldwide Distribution: US (nationwide) including states of: AZ, CA, CO, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MT, NC, NV, NY, OH, PA, TN, TX, VA, WA, and WI; and countries of: Canada, Australia, Austria, Belgium, Czech Republic, France, Germany, India, Israel, Italy, Japan, Malaysia, Russia, South Africa, Switzerland, and United Kingdom.

    Quantity

    1130