Rappel de Device Recall Trabecular Metal

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, 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
    65502
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1954-2013
  • Date de mise en oeuvre de l'événement
    2013-06-28
  • Date de publication de l'événement
    2013-08-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2015-03-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Cause
    There is potential for one or both tabsof thetrabecular metal reverse glenosphere helmet to fracture during use and become disassociated from the device. there have been 47 reported complaints of tab fracture.
  • Action
    Zimmer Inc sent Urgent Medical Device Recall notifications on June 28, 2013, to all affected customers. The initial letter identified the issue, possible adverse consequences and informed customers that a replacement would be available in the coming months. In addition, the letter included references to both the TM Reverse Surgical Technique and to the video available on Zimmer TV and Zimmer.com. Both resources explain in detail the proper technique for utilization of the Glenosphere Helmet. Proper utilization of the Glenosphere Helmet dramatically reduces the likelihood of fracture. Distributors will receive a copy of the surgeon letter for their reference along with the list of affected surgeons. The affected surgeons will be identified using invoice data and in cases where the surgeon is unknown, the distributor will be instructed to assist with the surgeon list. In addition, information regarding the return process for the damaged devices will be included. Questions and concerns are directed to Zimmer's customer call center (1-877-946-2761). Phase 2: As replacement devices with the new design became available for distribution, a 2nd letter was sent to the distributors. Estimated replacement device availability will begin in July 2013. The distributors will be instructed to order replacement devices as a means of completing the affected instrument cases in circulation within their territories. Instructions for the return of devices were included. For questions regarding this recall call 800-613-6131.

Device

  • Modèle / numéro de série
    60720060 60729529 60782351 60875299 60902349 60948238 60943023 60985367 61019824 61034822 61063216 61145917 61183670 61207699 61218854 61356595 61400936 61515555 61566478 61615548 61756075 61780197 61832594 61864229 61923988 61978214 62041752 62136099 62180444 62226761 and 62289420
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Korea, Lebanon, Malta, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, Utd.Arab.Emir.
  • Description du dispositif
    REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 40 mm Diameter Nonsterile, Qty -1 || Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to impaction with the glenospere impactor.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Société-mère du fabricant (2017)
  • 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