BEUDAMED
    FDA Recall Terminated

    SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during trial reduction.

    Recall: Z-0787-2016 · Initiated January 8, 2016

    Recall

    Recall Number
    Z-0787-2016
    Event Number
    73076
    Firm
    DePuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    LRY
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    January 8, 2016
    Posted
    February 9, 2016
    Terminated
    March 24, 2017
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during trial reduction.

    Reason

    Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. This may cause the surgeon to select an insert that is too thin. Surgical delay may result if the punch dislodges from the inserter and needs to be removed from the joint space. Insert Dislocation or Spin Out, or Poor Joint Mechanics may result, if not noted during surgery. May require revision surgery.

    Action

    On 1/8/2016, URGENT INFORMATION RECALL NOTICE for Specific Lots of SIGMA High Performance (HP) MBT Non-Keel Punch Knee Instrument notifications were sent to the affected distributors and Medical Professionals with instructions for identifying and returning the affected product. 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. For clinical questions from surgeons, please contact DePuy Orthopaedics, Inc.s Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m. 5 p.m. EDT). For questions about the device recall information provided, please contact Kim Earle, Senior Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. 5 p.m. EDT).

    Distribution

    Worldwide Distribution-US Nationwide, Armenia, Australia, Austria, Belgium, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, P R China, Portugal, Poland, Russia, Singapore, Slovenia, South Africa, Spain, Sweden, South Korea, Switzerland, Thailand, Turkey, UAE, UK, and Brazil.

    Quantity

    351