BEUDAMED
    FDA Enforcement Class II Terminated

    PALLAS M/MAXIMIS Poly Screw 6.5 x 45mm. 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-2901-2017 · Reported August 16, 2017

    Enforcement

    Recall Number
    Z-2901-2017
    Event ID
    77500
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Valorem Surgical LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 16, 2017
    Initiation Date
    June 21, 2017
    Classification Date
    August 10, 2017
    Termination Date
    November 27, 2018
    Address
    3963 W Belmont Ave Ste 9, N/A, Chicago, IL, 60618-5129, United States

    Description

    PALLAS M/MAXIMIS Poly Screw 6.5 x 45mm. 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.

    Code Info

    Catalog No. P365-045; Known Lot No. WNV110513.

    Distribution

    Nationwide Distribution - US including CA and VA.

    Quantity

    2,225 units total