BEUDAMED
    FDA Enforcement Class II 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 · Reported February 17, 2016

    Enforcement

    Recall Number
    Z-0787-2016
    Event ID
    73076
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 17, 2016
    Initiation Date
    January 8, 2016
    Classification Date
    February 9, 2016
    Termination Date
    March 24, 2017
    Address
    700 Orthopaedic Dr, N/A, Warsaw, IN, 46582-3994, United States

    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.

    Code Info

    Cat. No. GTIN Lot Description 950502016 10603295227366 ABB92402 SIGMA HP MBT Cemented Punch size 1-1.5 950502017 10603295227373 ABB84491 SIGMA HP MBT Cemented Punch size SZ 2-3 950502018 10603295227380 ABB92358 SIGMA HP MBT Cemented Punch size SZ 4-7 950502020 10603295227403 ABC33125 SIGMA HP MBT Noncemented Punch size 2-3 950502020 10603295227403 ABB81733 SIGMA HP MBT Noncemented Punch size SZ 2-3 950502020 10603295227403 ABB81732 SIGMA HP MBT Noncemented Punch size SZ 2-3 950502021 10603295227410 ABB39952 SIGMA HP MBT Noncemented Punch size SZ 4-7 950502021 10603295227410 ABC33123 SIGMA HP MBT Noncemented Punch size SZ 4-7

    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