BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2604-2018 · Initiated February 13, 2017

    Recall

    Recall Number
    Z-2604-2018
    Event Number
    80499
    Firm
    New Era Orthopaedics, LLc
    FEI Number
    3010760160
    Product Code
    MNI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 13, 2017
    Terminated
    November 7, 2018
    Address
    1214 Research Blvd, Ste 1019, Hummelstown, PA, 17036-9153

    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.

    Action

    On February 13, 2017, the firm emailed its distributors to notify them that their Rev. A devices would be replaced with Rev. B devices, and asked the distributors to mail back the Rev. A devices.

    Distribution

    2 distributors in CO and TX.

    Quantity

    6 pieces