BEUDAMED
    FDA Enforcement Class II Terminated

    Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The System is comprised of single use pedicle screws of varying reduction height, rods, rod connectors, etc. and an accompanying set of reusable surgical instruments. Some of the surgical instruments are specific to the system and others are general surgical instruments. The polyaxial screwdriver is specific to the polyaxial screws in the system.

    Recall: Z-0938-2014 · Reported February 19, 2014

    Enforcement

    Recall Number
    Z-0938-2014
    Event ID
    67350
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 19, 2014
    Initiation Date
    January 22, 2014
    Classification Date
    February 7, 2014
    Termination Date
    December 17, 2014
    Address
    311 Enterprise Dr, N/A, Plainsboro, NJ, 08536-3344, United States

    Description

    Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The System is comprised of single use pedicle screws of varying reduction height, rods, rod connectors, etc. and an accompanying set of reusable surgical instruments. Some of the surgical instruments are specific to the system and others are general surgical instruments. The polyaxial screwdriver is specific to the polyaxial screws in the system.

    Reason

    Integra LifeSciences has identified through an investigation of complaints that there may be the potential for the shaft of the Malibu Polyaxial Drivers to break during use. None of the complaints reported a patient injury. However, some complaints did indicate the surgery was slightly prolonged while the additional driver provided in the kit was retrieved and used.

    Code Info

    Model Number(s): 91-2109 (8.0 Plus) 91-2110 (Standard). Lot AL549784F: 91-2109 Malibu Polyaxial Screwdriver 8.0 Plus. Lot AL552404F: 91-2110 Malibu Polyaxial Screwdriver Standard. Lot AL546768F: 91-2110 Malibu Polyaxial Screwdriver Standard. The devices are not distributed as sterile and do not have a expiration date.

    Distribution

    Worldwide Distribution - USA including IA, FL, LA, IL, CA, TX, AZ, NC, MD, NM, VA, and Internationally to South Africa.

    Quantity

    40