BEUDAMED
    FDA Enforcement Class II Terminated

    Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100

    Recall: Z-2160-2019 · Reported August 14, 2019

    Enforcement

    Recall Number
    Z-2160-2019
    Event ID
    83345
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 14, 2019
    Initiation Date
    June 18, 2019
    Classification Date
    August 5, 2019
    Termination Date
    May 22, 2020
    Address
    2 Pearl Ct, N/A, Allendale, NJ, 07401-1611, United States

    Description

    Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100

    Reason

    Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the required 90mm length; lot B90243 100mm screws were manufactured with a 90mm length instead of the required 100mm length.

    Code Info

    Lot # B88751 UDI: (01)07613327351576(11)190125(10)B88751

    Distribution

    US Nationwide Distribution - CA, FL, GA, MA, NY, PA, TX

    Quantity

    11