Events

Rappel de Device Recall Herga foot switch, a component of ROSA Surgical Device

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 Zimmer Biomet, Inc..

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
    77614
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3117-2017
  • Date de mise en oeuvre de l'événement
    2016-01-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-04-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156850
  • 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
    Complaints were received reporting the system would freeze/shut down while in fulgurate mode.
  • Action
    Zimmer Biomet sent an Urgent Medical Device Recall Correction letter dated July 26, 2017, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product. for all surgical procedures, notify and ensure affected personnel are aware of the contents, complete the attached Certificated of Acknowledgement and return a digital copy. Customers with questions were instructed to call +33 (0) 467 107740, US customers should call 800-874-7711, ext 9225 .The initial correction was conducted by the manufacturer on January 20, 2016 with two of the 32 affected units which were imported into the U.S. being corrected by a customer representative. For questions regarding this recall call 574-267-6131.

Device

Device Recall Herga foot switch, a component of ROSA Surgical Device
  • Modèle / numéro de série
    Serial numbers for ROSA devices with the Herga Footswitch in US distribution: Serial No. RO10009, RO10011, RO10014, RO13023, RO13027, RO14033, RO14035, RO14037, RO14038, RO14039, RO14040, RO14041, RO14043, RO15044, RO15045, RO15046, RO15048, RO15050, RO15051, RO15052, RO15053, RO15054, RO15058, RO15059, RO15060, RO15061, RO15062, RO15063, RO15064, RO15067, RO15069, and RO14031.  Serial numbers for ROSA devices with the Herga Footswitch in foreign distribution: Serial No. RO08003, RO09004, RO09005, RO10007, RO10010, RO10013, RO11015, RO11016,  RO11017, RO12018, RO12019, RO12020, RO12021, RO12022, RO13024,  RO13025, RO13026, RO14029, RO14030, RO14032, RO14034, RO14036,  RO14042, RO15047, RO15049, RO15055, RO15056, RO15057, RO15065,  RO15066, RO15068, and RO15070.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain and the United Kingdom.
  • Description du dispositif
    Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Edmunds, Suffolk IP32 6NN. || 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
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Adresse du fabricant
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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