Events

Rappel de Device Recall Pulsavac

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 Orthopaedic Surgical Products.

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
    46206
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0857-2008
  • Date de mise en oeuvre de l'événement
    2007-12-18
  • Date de publication de l'événement
    2008-03-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66968
  • 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
    Jet Lavage - Product Code FQH
  • Cause
    Sterility (package integrity) compromised; the effect of a silicone stain produced during assembly operations on the sterility barrier properties of the tyvek lids has not been validated by the firm.
  • Action
    Zimmer notified their customers via an Urgent Device Recall letter dated January 8, 2008. The letter requests each customers to inventory their stock. If any recalled product is located the customer is to notify Zimmer via fax and a replacement part will be shipped to them.

Device

Device Recall Pulsavac
  • Modèle / numéro de série
    Lot Numbers: 60622533, 60642558, 60654878, 60656842, 60693312, and 60725489
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide-USA, forty-two international and one Canadian account, including countries of Singapore, Hong Kong, Lebanon, Finland, Australia, Japan, Israel, Korea, Saudi Arabia, Dubai, Denmark, Czech Republic, Guatemala, Brazil, Taiwan, China, Nicaragua, Virgin Island, Switzerland, Austria, Spain, Belgium, The Netherlands, France, Germany, Portugal, England, Sweden, India, Argentina, Italy, Chile, Thailand & Saudi Arabia
  • Description du dispositif
    Pulsavac Plus AC Component Kit, Catalog #00-5150-426-01, 1 kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
  • Manufacturer
    Zimmer Orthopaedic Surgical Products

Manufacturer

Zimmer Orthopaedic Surgical Products
  • Adresse du fabricant
    Zimmer Orthopaedic Surgical Products, 200 W Ohio Ave, Dover OH 44622-9642
  • 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