BEUDAMED
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    FDA Recall
    Terminated ·Medtronic Sofamor Danek Instrument Manufacturing·Product code HXX·December 22, 2005

    Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile.

    FDA Recall
    Terminated ·Orthofix, Inc·Product code HXX·April 27, 2016

    Gamma 3 System Set Screwdriver, Flexible Shaft; 4mm, This product is non-sterile Stryker Trauma GmbH, Germany; Distributed by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 - Orthopedic Device. The Gamma3 Locking Nail Systems are intramedullary short and long fixation nails intended for control of rotation and shortening of fractured femurs. The screwdriver is used to place the set screw in the nail.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HXX·February 22, 2008

    Optilock T15 AO Driver (3.5mm). Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone. The System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone. The OptiLock VL Distal Radius Plating System is intended for use in distal radius and ulna (and other small bones), including use in osteopenic bone.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code HXX·August 23, 2012

    Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178

    FDA Recall
    Terminated ·Ebi, Llc·Product code HXX·September 29, 2012

    Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone. The System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone. The OptiLock VL Distal Radius Plating System is intended for use in distal radius and ulna (and other small bones), including use in osteopenic bone.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code HXX·August 23, 2012

    Normed TX 8 Driver, Non-Cannulated (used with the Ascension Total Foot System); Catalog #503004268; distributed by Ascension Orthopedics, Inc., Austin, TX 78754. Orthopedic manual surgical screwdriver.

    FDA Recall
    Terminated ·Ascension Orthopedics, Inc·Product code HXX·April 14, 2009

    DRIVER STAR #8 CANNULATED DART-FIRE (TM), COMPRESSION SCREW, SIZE: #8, REF: DSDS-0008, 1 EACH, Rx ONLY, NON-STERILE, EC REP Wright Medical EMEA, Krijgsman 11, 1186 DM Amstelveen, The Netherlands, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002

    FDA Recall
    Terminated ·Wright Medical Technology Inc·Product code HXX·August 26, 2010

    Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.

    FDA Recall
    Terminated ·SpineFrontier, Inc.·Product code HXX·May 10, 2013

    T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of the removal head and used to disengage the remaining portion of the set screw within the device.

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code HXX·August 12, 2013

    Atlantis Anterior Cervical Plate System Screw Driver, Part number 876-482

    FDA Recall
    Terminated ·Medtronic Sofamor Danek Instrument Manufacturing·Product code HXX·November 28, 2005

    Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.

    FDA Recall
    Terminated ·Ebi, Llc·Product code HXX·February 7, 2013

    InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to install the InSpan Spinous Plate System for the purpose of achieving supplemental fixation.

    FDA Recall
    Terminated ·SpineFrontier, Inc.·Product code HXX·May 7, 2013

    Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletal mature patients for use with autograft and/or allograft. The device is indicated for all the following indications:degenerative disc disease (defined as discogeneic back pain with degeneration of the disk confirmed by history and radiographic studies), spondylolisthesis, and or lordosis) tumor, stenosis, pseudoarthrosis, or failed previous fusion

    FDA Recall
    Terminated ·Ebi, Llc·Product code HXX·September 24, 2013

    MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code HXX·October 25, 2021

    Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.

    FDA Recall
    Terminated ·Trilliant Surgical, LLC·Product code HXX·March 14, 2019

    PERPOS PLS System, Single Use; CATALOG #'s 9045-01 & 9045-02. Interventional Spine, Inc. A sterile kit used to stabilize the spine as an aid to fusion through immobilization of the facet joints.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code HXX·February 3, 2011

    Pathfinder NXT Closure top driver - short, REF 3566-2, Zimmer Inc., Warsaw, IN Product Usage: The Closure Top Driver is used in conjunction with compressors, distractors, and reducers, as needed, to manipulate and hold the spine into the desired position via loosening/tightening maneuvers on the provisionally inserted closure tops of the construct assembly. After confirmation of correct screw and rod placement, the Closure Top Driver is used to apply final torque to the provisionally tightened closure tops to secure the construct assembly. The Closure Top Driver is also used to remove previously inserted closure tops during construct removal.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HXX·May 20, 2011

    PERPOS Driver; Catalog # 6112 Interventional Spine, Inc. A cannulated, driver to be used over a K-wire to engage the head of the 4.5mm BONE-LOK PLS Implant (LSW-45-3040) and drive it into the bone. The PERPOS Driver (61 12) is sold as either a component of the Single Use PERPOS PLS System (9045-01, 9045-02), a component of the Reusable BONE-LOK PLS System (9039-01, 9039-02), or as a stand-alone tool.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code HXX·February 3, 2011

    SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code HXX·January 3, 2014