BEUDAMED
    FDA Enforcement Class II Terminated

    PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.

    Recall: Z-0544-2014 · Reported December 25, 2013

    Enforcement

    Recall Number
    Z-0544-2014
    Event ID
    66698
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SpineFrontier, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    December 25, 2013
    Initiation Date
    October 18, 2013
    Classification Date
    December 19, 2013
    Termination Date
    August 22, 2016
    Address
    500 Cummings Ctr Ste 3500, N/A, Beverly, MA, 01915-6516, United States

    Description

    PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.

    Reason

    During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip head and an 8mm screw. A recall was initiated to remove all remaining screws of the same lot from the field to investigate the nonconformity.

    Code Info

    Lot/Serial Numbers: 357305-000

    Distribution

    US Distribution to VA and TX.

    Quantity

    35 Devices