Events

Rappel de Slotted Femoral Head Provisional

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
    62110
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2484-2012
  • Date de mise en oeuvre de l'événement
    2011-04-01
  • Date de publication de l'événement
    2012-09-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-05-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112442
  • 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
    Template - Product Code HWT
  • Cause
    Complaints have been received reporting sub-optimal fit between provisional femoral heads (versys and mis) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. intraoperative dislodging of the provisional head and the provisional head being left in-vivo after separating from mating comp.
  • Action
    Zimmer, Inc. sent an E-mail letter dated April 21, 2011, to all affected customers in the US. A June 2011 E-mail was sent to all customers outside the US. The letters requested Inventory & Operations Managers to check product for proper fit /function, complete the return form with worn provisional heads to Zimmer Inc, Attention Product Service, 1777 West Center St. Warsaw, IN 46580. For questions regarding this recall call 574-372-4753.

Device

Slotted Femoral Head Provisional
  • Modèle / numéro de série
    All lots including lot 78939000 (1/7/2002) to present
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea.
  • Description du dispositif
    00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 || 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 || 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 || 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 || 00780304005 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 || The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Adresse du fabricant
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 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