Events

Rappel de Device Recall ROSA(TM) Robotized Stereotactic Assistant

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par MEDTECH SAS.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    80061
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2108-2018
  • Date de mise en oeuvre de l'événement
    2018-05-08
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164315
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Neurological stereotaxic Instrument - Product Code HAW
  • Cause
    Replacement of units lacking an updated device approval.
  • Action
    Medtech would like to inform you of the planned removal of all ROSA 2.5 devices from the US market by 31st October 2018. The ROSA 2.5 design has been superseded by a newer generation product, ROSA Brain 3.0, and a decision has been made by Zimmer Biomet to exchange all ROSA 2.5 devices in the US market with ROSA Brain 3.0 devices. This decision has been taken in response to a regulatory clearance compliance issue, and there is no safety concern associated with this action. No specific action is required and the ROSA 2.5 can continue to be used at this time. A Medtech representative will be in contact to schedule the exchange of the RO 15 061 device with a ROSA Brain 3.0 device. For further questions, please call (574) 371-3071.

Device

Device Recall ROSA(TM) Robotized Stereotactic Assistant
  • Modèle / numéro de série
    Serial Numbers: RO 10 009, RO 10 011, RO 10 014, RO 13 023, RO 13 027, RO 14 031, RO 14 033, RO 14 035, RO 14 038, RO 14 039, RO 14 040, RO 14 041, RO 14 043, RO 15 044, RO 15 045, RO 15 046, RO 15 050, RO 15 051, RO 15 052, RO 15 053, RO 15 054, RO 15 058, RO 15 059, RO 15 060, RO 15 061, RO 15 063, RO 15 064, RO 15 067, RO 15 069
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution
  • Description du dispositif
    ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 || ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.
  • Manufacturer
    MEDTECH SAS

Manufacturer

MEDTECH SAS
  • Adresse du fabricant
    MEDTECH SAS, Parc Euromedecine Batiment 8, 1006 rue de la Croix Verte, Montpellier France
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA