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    Breaking News

    Zimmer Biomet Recalls ROSA Brain 3.0 Robotic Surgery System

    The device is being recalled due to a software issue that incorrectly positions the robotic arm.

    Zimmer Biomet Recalls ROSA Brain 3.0 Robotic Surgery System
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    • 3. Zimmer Biomet
    U.S. Food and Drug Administration11.08.19
    The FDA has identified this as a Class I recall, the most serious type of recall.  Use of these devices may cause serious injuries or death.
     
    Recalled Product
     
    Recalled Product(s): ROSA Brain v3.0.0.0 and v3.0.0.5
    Product Codes: See a full list
    Manufacturing Dates: February 23, 2016 to December 21, 2018 
    Distribution Dates:  April 8, 2016 to March 19, 2019
    Devices Recalled in the U.S.: 86
    Date Initiated by Firm: September 10, 2019
     
    The ROSA Brain device is a robotic platform that assists neurosurgeons in positioning medical instruments or implants during surgery. The device is composed of a compact robotic arm and a touch screen mounted on a stand. Different types of instruments may be attached to the end of the robotic arm depending on the procedure to be completed.
     
    Zimmer Biomet recalled the ROSA Brain Device due to a software issue with ROSA Brain v3.0.0.0 (v3.0.0.16 software) and ROSA Brain v3.0.0.5 (v3.0.0.20 software, collectively referred to as v3.0 software), which can drive the robotic arm to an incorrect position resulting in risks for the patient.
     
    Zimmer Biomet has received five complaints related to this issue, including one patient injury. No deaths related to this issue have been reported.
     
    Neurosurgeons and assisting medical personnel who use the ROSA Brain device in the operating room and patients receiving neurosurgery during which the ROSA Brain device is used may be affected.
     
    On September 10, 2019, Zimmer Biomet issued an Urgent Medical Device Correction to customers, advising them of the product issue, recommendations, and next steps:
     
    • Costumers should refer to the Urgent Device Correction letter for instructions for a workaround for the issue. Customers were also advised of the workflow that would cause the problem to occur.
    • Zimmer Biomet stated that they would provide a label containing the workaround instructions that could be applied directly to the unit by September 30, 2019.
    • A Zimmer Biomet engineer will be deployed to each customer site to implement software version 3.1 to correct the issue.
    • Zimmer committed to contacting customers by October 31, 2019 with additional information regarding this planned update and the estimated timing.
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    Related Breaking News

    • Spine/Neurology
      InVivo Therapeutics Attains 25 Percent Enrollment in Spinal Cord Injury Study

      InVivo Therapeutics Attains 25 Percent Enrollment in Spinal Cord Injury Study

      Fourteen sites currently are open for patient enrollment.
      Business Wire 12.09.19

    • BioPrax Biofilm Disruption Device Granted FDA Breakthrough Device Designation

      BioPrax Biofilm Disruption Device Granted FDA Breakthrough Device Designation

      Product is designed to help eliminate biofilm infections on prosthetic knee implants during early intervention procedures.
      PR Newswire 12.09.19

    • Spine/Neurology
      Orthofix Appoints New Spine Business Leader

      Orthofix Appoints New Spine Business Leader

      Kevin Kenny was previously VP of U.S. sales for Spine and Biologics at Medtronic.
      Business Wire 12.05.19


    • Packaging & Sterilization
      Viant to Halt EtO Sterilization at Michigan Plant by End of Year

      Viant to Halt EtO Sterilization at Michigan Plant by End of Year

      EGLE had been investigating over the past year and issued Viant several violations for inadequate capture and control of ethylene oxide emissions.
      Michigan Department of Environment, Great Lakes, and Energy (EGLE) 12.04.19

    • Spine/Neurology
      Synaptive Medical

      Synaptive Medical's Modus V Expands Into Spine Market

      Modus V’s robotic arm moves automatically based on the positions of tracked surgical instruments.
      Business Wire 12.04.19

    • 3-D Printing/Additive Mfg. | Biologics | Materials
      3D-Printed Graftless Bone Transplants Go to Clinical Trials

      3D-Printed Graftless Bone Transplants Go to Clinical Trials

      ADAM is piloting the use of ceramics and polymer in 3D-printed bone implants, able to be produced at commodity prices.
      PR Newswire 12.04.19


    • Extremities
      CrossRoads Extremity Systems Acquires Implant Systems from Surgical Frontiers

      CrossRoads Extremity Systems Acquires Implant Systems from Surgical Frontiers

      The add-on acquisition furthers CrossRoads' strategy to build a market-leading company in the high-growth orthopedic extremities sector.
      PR Newswire 12.04.19

    • Spine/Neurology
      Micro Spine Implant Could Restore Standing and Walking

      Micro Spine Implant Could Restore Standing and Walking

      Hair-like electrical wires send electrical signals to trigger networks that already know how to do the hard work.
      University of Alberta Faculty of Medicine & Dentistry 12.03.19

    • Spine/Neurology
      RTI Surgical Appoints New Division Leaders

      RTI Surgical Appoints New Division Leaders

      Terry Rich, experienced spine leader, named president, Global Spine; Olivier Visa elevated to president, Global OEM.
      GlobeNewswire 12.03.19


    • KCI Introduces Solution for Challenging Surgical Locations

      KCI Introduces Solution for Challenging Surgical Locations

      Company's latest technology targets post-operative incisions and surrounding soft tissue.
      Business Wire 12.03.19

    • EOS Imaging Receives FDA 510(k) Clearance for Next-Gen Imaging System

      EOS Imaging Receives FDA 510(k) Clearance for Next-Gen Imaging System

      EOSedge will be unveiled at the RSNA Annual Meeting.
      Business Wire 12.02.19

    • Large Joint
      mediCAD is Now Officially a Medical Device in Japan

      mediCAD is Now Officially a Medical Device in Japan

      The product is an orthopedic planning solution for hip, knee, shoulder, hand, leg, or spine surgery.
      mediCAD Hectec GmbH 12.02.19

    • Imaging
      New Generation Imaging System Launched in Europe and Canada

      New Generation Imaging System Launched in Europe and Canada

      EOS Imaging will unveil its EOSedge at the upcoming Radiological Society of North America (RSNA) 2019 Annual Meeting.
      Business Wire 11.26.19

    • Software & Quality
      Survey Identifies Challenges to Improving Product Development Processes

      Survey Identifies Challenges to Improving Product Development Processes

      81% of medical device companies are not using tools designed for the medical device industry in their quality management processes.
      PRWeb 11.26.19

    • Extremities
      Arthrosurface Introduces the SpiralUp TCL Allograft System

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      Joint-preserving allograft addresses ankle instability and benefits the entire musculoskeletal system.
      Arthrosurface Inc. 11.26.19


    Breaking News
    • InVivo Therapeutics Attains 25 Percent Enrollment in Spinal Cord Injury Study
    • BioPrax Biofilm Disruption Device Granted FDA Breakthrough Device Designation
    • Orthofix Appoints New Spine Business Leader
    • Viant to Halt EtO Sterilization at Michigan Plant by End of Year
    • Synaptive Medical's Modus V Expands Into Spine Market
    View Breaking News >
    CURRENT ISSUE

    November/December 2019

    • From Nitinol to Nanotubes: A Materials Science Roundtable
    • In Good Repair: Trauma Technologies Under Review
    • Anxious Undertones: A Review of 2019
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