BEUDAMED
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    Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC300

    FDA Recall
    Terminated ·Medtronic Xomed, Inc.·Product code ERL·December 15, 2021

    Foot Control, SC2100 Product Usage: Electric system

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code ERL·October 6, 2016

    Anspach Xmax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code ERL·December 18, 2006

    ***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code ERL·April 25, 2013

    ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code ERL·March 28, 2016

    Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures.

    FDA Recall
    Terminated ·Medtronic Xomed, Inc.·Product code ERL·June 12, 2020

    Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code ERL·October 6, 2016

    Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and cranium.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code ERL·May 6, 2013

    Anspach BlackMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code ERL·December 18, 2006

    Anspach MicroMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code ERL·December 18, 2006

    ***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code ERL·April 25, 2013

    XMAX Motor (Pneumatic Drill System) Product Usage: Pneumatic system

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code ERL·October 6, 2016

    ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only*** This device is intended to be used with Anspach Systems

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code ERL·November 28, 2012

    ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code ERL·March 28, 2016

    2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub. ENT Precision Cutter, Aggressive, ESSxlHUMMER 4, Rx Only It is used for ENT procedures and functions by means of rotation when adapted to a handpiece and console. Through the rotation, the necessary tissue is resected as required by the user. The blade housing has an etching line guide that starts with a straight line and along with a scale from 1cm to 7cm in 1cm increments that serves the doctor as a guide by indicating how far the device is being introduced into the surgical area.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code ERL·March 18, 2014

    ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intended to be used with Anspach Systems

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code ERL·November 28, 2012

    ANSPACH***REF 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Custom Autolube III IRR Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code ERL·November 28, 2012

    Foot Control without Switches, SC2100 Product Usage: Electric system

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code ERL·October 6, 2016

    XMAX Motor, High Strength Hose Product Usage: Pneumatic system

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code ERL·October 6, 2016

    Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code ERL·July 1, 2013