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 Microfixation, 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
  • ID de l'événement
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
  • Date de mise en oeuvre de l'événement
  • Date de publication de l'événement
  • Statut de l'événement
  • Pays de l'événement
  • Date de fin de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • 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
    Plate, bone - Product Code JEY
  • Cause
    Biomet microfixation is recalling model 01-7293 an model 99-7293-01, 1.5x3.5mm self drilling, low profile, cross drive screw, 5/pk was found to contain a 91-6104 (1.5x4mm high torque, self drilling, cross drive screw.
  • Action
    Biomet Microfixation Issued an "Urgent Medical Device Recall Notice". Consignees were notified of the recall instructed to indentify and return all affected product to the firm. An Inventory Reconciliation sheet should be completed and faxed to 1-904-741-9425. For further information, contact Biomet Microfixation, Global Complaint Coordinator at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.


  • Modèle / numéro de série
    Lot Numbers: 813480, 114360, 498480, 753270, WL2340 and 031830.
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Worldwide Distribution -- United States (WI), Spain, Italy, Japan, Brazil and Korea.
  • Description du dispositif
    BIOMET MICROFIXATION, "1.5MM" SYSTEM BONE SCREW LP, SELF DRILL, X-DRIVE, SGL.LEAD AUGER POINT, 1.5 X 3.5MM, TITANIUM, NON STERILE PRODUCT. Model 01-7293 and 99-7293-01. BIOMET MICROFIXATION, 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA. || Used along with implantable bone plates for oral, cranio-maxillofacial procedures including: Fractures, Osteotomies (including orthognathic procedures), reconstructive procedures & revision procedures where other treatments or devices have failed.
  • Manufacturer


  • Adresse du fabricant
    Biomet Microfixation, Inc., 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • Société-mère du fabricant (2017)
  • 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