Events

Rappel de Device Recall NEXGEN COMPLETE KNEE SOLUTION POSTERIOR REFERENCING SIZER BOOM

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
    58225
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1987-2011
  • Date de mise en oeuvre de l'événement
    2011-03-14
  • Date de publication de l'événement
    2011-04-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-03-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98762
  • 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
    prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
  • Cause
    The firm is initiating a recall due to the potential for breakdown of the altin pvd (black) coating during surgery and the coating could fall into the surgical site. the firm has received 22 reports of the black coating coming off the instruments after cleaning and sterilization cycles and 5 resulted in a delay of surgery.
  • Action
    The firm, Zimmer, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 14, 2011 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Instructions for Handling of Affected Product: 1) Stop using the devices and to quarantine immediately 2) Carry out a physical count of all affect product in their territory and record data on Inventory Identification Form included with this letter-Note: The instruments must be returned even if the instrument is not exhibiting the black powder 3)Ensure they have provided acknowledgement via "email return receipt" upon receiving this notification 4) Fax copy of completed form to (574) 372-4265 5) Return the recalled product along with the completed Inventory Identification Form and the Sterilization Certification Form to: Zimmer Distribution Center, Attn: Product Service, 1777 West Center Street, Warsaw, IN 46580 A new or refurbished instrument will be provided as replacement for their returned product once the inventory is available. Instructions for Health Care Professional Notification 1) Provide a list of all hospital that currently use or have used the affected product listed in notice by utilizing the User Facility Documentation Form and the Health Care Professional Documentation Form 2) Fax a copy of the completed form(s) to: Zimmer, Inc. at (574) 372-4265 Zimmer will provide a similar notification via FedEx to these hospitals making them aware of this recall and provide a "Dear Doctor" letter for their surgeons. Important: If you have distributed these affected lots further, please provide a copy of this letter to these customers when you implement these recall instructions. For shipping assistance, questions or assistance in notifying your accounts about the recall, please contact Zimmer, Inc., at 1-800-613-6131. ADDENDUM INFO The information listed above was updated to include the additional 5

Device

Device Recall NEXGEN COMPLETE KNEE SOLUTION POSTERIOR REFERENCING SIZER BOOM
  • Modèle / numéro de série
    REF 00-5901-040-10, Lots 61505400, 61558201, 61570225, 61574608, 61580669, 61585371 and 61594877
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Australia, Canada, Germany, Japan, New Delphi and Singapore. Addendum: Finland, Switzerland, UK, Denmark, Spain, Portugal, France, Netherlands, Italy, South Africa, Norway, Spain, and Sweden.
  • Description du dispositif
    Posterior Referencing Instrumentation for the NEXGEN¿ COMPLETE KNEE SOLUTION POSTERIOR REFERENCING SIZER Boom, REF 00-5901-040-10, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN || This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Adresse du fabricant
    Zimmer 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