Events

Rappel de Device Recall Optigun Ratchet

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 BIOMET FRANCE S.A.R.L..

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
    71365
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1744-2015
  • Date de mise en oeuvre de l'événement
    2015-05-14
  • Date de publication de l'événement
    2015-06-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-10-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137454
  • 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
    Dispenser, cement - Product Code KIH
  • Cause
    The pin which maintains the knob button, may disconnect and become lost. this may result in a delay of surgery to obtain a new optigun and detect/retrieve the pin, and may necessitate revision surgery if the pin falls into the surgical site and is not detected.
  • Action
    BIOMET sent an URGENT ADVISORY NOTICE dated May 14, 2015, to all affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to check the product to identify to determine if the pin is defective, if defective they should return it to Biomet Warsaw, following the directions on the Response Form and confirm receipt of the notice by sending back the response form. Questions related to this notice should be directed to (574) 372- 1570 Monday through Friday 8 a.m. to 5 p.m.

Device

Device Recall Optigun Ratchet
  • Modèle / numéro de série
    Catalog number: 419500 Lot number: 0101296012
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution to MD only
  • Description du dispositif
    The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.
  • Manufacturer
    BIOMET FRANCE S.A.R.L.

Manufacturer

BIOMET FRANCE S.A.R.L.
  • Adresse du fabricant
    BIOMET FRANCE S.A.R.L., plateau de lautagne, valence cedex 9, Valence Cedex 9 France
  • 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