Events

Rappel de Device Recall CURVTEK EYE NEEDLE, 12 MM LARGE

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
    58241
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1903-2011
  • Date de mise en oeuvre de l'événement
    2011-03-10
  • Date de publication de l'événement
    2011-04-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-07-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98788
  • 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
    Needle, suturing, disposable - Product Code GAB
  • Cause
    The firm initiated a recall due to the discovery that the devices were not sterilized, as required, prior to distribution.
  • Action
    The firm, BIOMET, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated March 10, 2011 to all customers. The letter described the product, problem and actions to be taken. The letter noted that -Use of a non-sterile Curvtek Eye Needle may lead to patient infection, possibly requiring a revision procedure. The customers were instructed to immediately locate, discontinue use of the product , remove the product from circulation and return the product to Biomet; carefully follow the instructions on the enclosed FAX BACK RESPONSE FORM; complete and return the response form via fax to 574-372-1683 prior to return of product; use priority carrier for shipment, and please confirm receipt of this notice by calling 800-348-9500, extension 3755 or 3756. The firm also informed physicians that had previously utilized the device to monitor patients for infection and provide treatment as appropriate. Questions related to this notice should be directed to 574-371-3755 or 574-371-3756, Monday through Friday, 8am to 5pm.

Device

Device Recall CURVTEK EYE NEEDLE, 12 MM LARGE
  • Modèle / numéro de série
    Part Number 906764, Lots 748580, 748730 and 932650.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including states of: IN and KY; and countries of: Canada and The Netherlands.
  • Description du dispositif
    REF 906764, CURVTEK EYE NEEDLE, 12 MM LARGE, STAINLESS STEEL GAMMA STERILIZED, PKG/3, BIOMET SPORTS MEDICINE, 56 EAST BELL DRIVE, P.O. BOX 587, WARSAW, IN 46581 USA, STERILE || After the Curvtek device is used to drill a "C" shaped tunnel through the patient's bone, the device is used to pass suture through the tunnel so that soft tissue may be tied down directly onto the bone.
  • 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