BEUDAMED
    FDA Recall Terminated

    PALLAS M/MAXIMIS Extension Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

    Recall: Z-2988-2017 · Initiated June 21, 2017

    Recall

    Recall Number
    Z-2988-2017
    Event Number
    77500
    Firm
    Valorem Surgical LLC
    FEI Number
    3010212187
    Product Code
    MNI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 21, 2017
    Terminated
    November 27, 2018
    Address
    3963 W Belmont Ave, Ste 9, Chicago, IL, 60618-5129

    Description

    PALLAS M/MAXIMIS Extension Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

    Reason

    Devices are not consistent with Quality System Requirements.

    Action

    Valorem Surgical sent an Urgent Medical Device Recall letter dated June 21, 2017, informing consignees of the product removal and instructing consignees to return any product to Valorem Surgical LLC to minimize potential risk to patients. Consignees are to fill out the attached Medical Device Recall Return Response form and send it back to the firm by email at [email protected] or by fax at 312-275-7117, or by mail. For questions pertaining to this recall, please submit an email inquiry to [email protected]

    Distribution

    Nationwide Distribution - US including CA and VA.

    Quantity

    262 units total