Events

Rappel de Device Recall Disposable Dowel Harvest Tube

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, 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
    56522
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2601-2010
  • Date de mise en oeuvre de l'événement
    2010-07-01
  • Date de publication de l'événement
    2010-09-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93834
  • 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
    Bone Coring Device - Product Code LXH
  • Cause
    The affected instruments are discolored and/or have a sticky residue on the end.
  • Action
    The firm sent out "Urgent Medical Device Recall" notices dated 7/1/2010. Letters were sent to distributors, customers and OR managers. The letters stated that the devices should be located, quarantined and shipped back to the recalling firm. On 7/15/2010, the firm added one lot of one additional product to the recall (product 900788 lot 780470). The firm sent letters to physicians that had used that lot of product. Questions relating to this recall should be directed to 574-371-3755.

Device

Device Recall Disposable Dowel Harvest Tube
  • Modèle / numéro de série
    705630
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
  • Description du dispositif
    7 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900737, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. || Usage: Bone Coring Device used in ACL and PCL procedures.
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Adresse du fabricant
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582
  • 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