Events

Rappel de Device Recall BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER

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
    Recall
  • ID de l'événement
    51668
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1323-2009
  • Date de mise en oeuvre de l'événement
    2009-03-20
  • Date de publication de l'événement
    2009-05-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-09-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80924
  • 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, fixation, bone - Product Code HRS
  • Cause
    This recall is based on the occurrence of known adverse effects identified in the device instructions for use. bending, fracture, loosening, rubbing and migration of the devices can occur as a result of excessive activity, trauma or load bearing. implantation of foreign materials can result in an inflammatory response or allergic reaction.
  • Action
    An "Urgent Medical Device Recall Notice" was issued via certified letter or email on March 20, 2009 to consignees. Customers were instructed to immediately remove and return the affected in-stock product to Biomet Microfixation, Inc. Customers were also asked to complete and return the enclosed Inventory Reconciliation sheet via fax (904-741-9425) to the firm, and to notify recipients of any recalled products that had been further distributed. For questions about the recall, contact Biomet Microfixation at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm EST.

Device

Device Recall BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER
  • Modèle / numéro de série
    All lots.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- US (including DC and states of AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MI, MO, MN, NC, NE, NH, NJ, NM, NY, OH, OK, PA, TX, VA and WI) and countries of Argentina, Austria, Belgium, Chile, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Guatemala, Israel, Italy, Lativa, Netherlands, South Africa, Spain, Sweden, Turkey, United Arab Emirates, United Kingdom and Venezuela.
  • Description du dispositif
    Lactosorb Pectus Stabilizer, model number: 01-3805. Distributed and Manufactured by : Biomet Microfixation, Jacksonville, FL. || LactoSorb¿ Pectus Stabilizer is a surgical implant intended to aid in the treatment of Pectus Excavatum deformities. The LactoSorb¿ Pectus Stabilizer provides the surgeon with a means to secure the Pectus Support Bar to the chest wall. The Pectus Support Bar is used to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shaped deformity.
  • Manufacturer
    Biomet Microfixation, Inc.

Manufacturer

Biomet Microfixation, Inc.
  • Adresse du fabricant
    Biomet Microfixation, Inc., 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • 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