Events

Rappel de Device Recall SternaLock Blu Implant Tray

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
    60682
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0843-2012
  • Date de mise en oeuvre de l'événement
    2011-11-23
  • Date de publication de l'événement
    2012-01-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106198
  • 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
    Biomet microfixation, inc., jacksonville, fl recalled their sternalock blu implant tray on 11/23/11, model numbers 73-1300 through 73-1302 due to the possibility of an inaccurate reading on the screw measuring area. if used incorrectly, the screw measuring area inside the sternalock blu implant tray, could lead to the improper selection of a screw 2mm longer than needed.
  • Action
    Biomet Microfixation, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter provides a "Recommended Technique" to be followed to correct the problem until replacement trays are available. Contact the Quality Improvement Manager at 1-800-874-7711 for questions regarding this notice.

Device

Device Recall SternaLock Blu Implant Tray
  • Modèle / numéro de série
    Model Number 73-1300, Lot numbers: 032211, 042911, 100611. Model Number 73-1301, Lot numbers: 249640, 280130, 280131, 312560, 031411. Model Number 73-1302, Lot number: 011411.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution-- USA (nationwide) including the states of AL, AZ, CA, CO, DE, FL, GA, HI, IL, IN, KY, MD, MO, MS, NC, NE, NJ, NY, OK, OR, PA, SC, TN, TX, WA, and WI. and countries of Argentina, Australia, Canada, Denmark, Finland, Germany, South Africa, and Spain.
  • Description du dispositif
    The SternaLock Blu Implant Tray includes plates, screws, screw measuring device, and blades. || The SternaLock Blu Implant Tray would have been found within the following outer containers: || Silver Instrument Tray, with a White rack, and there is no Power Driver warning. || Labeled in part: "Manufactured for Biomet Microfixation***Biomet Microfixation 1520 Tradeport Drive Jacksonville, FL 32218 USA www.biometmicrofixation.com***#73-1301***STERNALOCK IMPLANT TRAY***256X 125.5 MM (10.080 x 4.940 ") (LXW)***Polypropylene, Aluminum, Stainless Steel***" || A 3" tall container, with blue rubber handles, and a Power Driver warning on the container lid. Labeled in part: "Manufactured for Biomet Microfixation***Biomet Microfixation 1520 Tradeport Drive Jacksonville, FL 32218 USA www.biometmicrofixation.com***#73-1302***STERNALOCK BLU IMPLANT TRAY SEMIMODULAR***256X 125.5 MM (10.080 x 4.940 ") (LXW)Polypropylene, Aluminum, Stainless Steel***" || A 5" tall container, with a wide metal latch to secure the lid, and there is no Power Driver warning. Labeled in part: "Manufactured for Biomet Microfixation***Biomet Microfixation 1520 Tradeport Drive Jacksonville, FL 32218 USA www.biometmicrofixation.com***#73-1300***STERNALOCK BLU IMPLANT SEMI MODULAR TRAY***228.6X 128.8MM (9.00 x 5.07 ") (LXW)Polypropylene, Aluminum, Radel***". || The Biomet Microfixation SternaLock Blu System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures to aid in the alignment and stabilization of bone. There SternaLock instrument tray has been designed specifically to store the implants for this system.
  • 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