BEUDAMED
    FDA Enforcement Class II Terminated

    Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07

    Recall: Z-2604-2018 · Reported August 15, 2018

    Enforcement

    Recall Number
    Z-2604-2018
    Event ID
    80499
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    New Era Orthopaedics, LLc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 15, 2018
    Initiation Date
    February 13, 2017
    Classification Date
    August 3, 2018
    Termination Date
    November 7, 2018
    Address
    1214 Research Blvd Ste 1019, N/A, Hummelstown, PA, 17036-9153, United States

    Description

    Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07

    Reason

    This is a retrospective recall of an instrument used in spine fusion procedures with Modera Modular Pedicle Screw system implants. The firm received a customer complaint in which excessive forces were applied to the shank insertion instrument and the laser weld failed.

    Code Info

    11125

    Distribution

    2 distributors in CO and TX.

    Quantity

    6 pieces