Events

Rappel de Latex Free Rubber Band

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
    59943
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0012-2012
  • Date de mise en oeuvre de l'événement
    2011-08-18
  • Date de publication de l'événement
    2011-10-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104047
  • 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
    Orthodontic elastic band - Product Code ECI
  • Cause
    On 09/18/2011, biomet microfixation, jacksonville, fl, recalled their sp-2411, rubber band, lot 307850 because it was labeled and sold as "latex free" although it contains "latex". the firm's hhe identified this as a potential high health risk to the patients or end users with latex allergies.
  • Action
    Biomet Microfixation, Jacksonville, FL sent a Urgent Medical Device letter dated August 19, 2011, to all affected customers. They were also notified by phone, and followed-up by e-mails starting on 08/18/2011. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed If you have any of the affected products in your facility, please remove it and return it immediately to Biomet Microfixation for credit. In order to return these products, please utilize the Return Goods Authorization (RGA) number provided on the reconciliation form. Please follow the instructions on the form and fill out the attached Inventory Reconciliation sheet and FAX to (904) 741-9425. If you have any further questions, please call 1-800-874-7711 or (904) -741-4400, extension 9468, Monday through Friday, 8am-4pm ET.

Device

Latex Free Rubber Band
  • Modèle / numéro de série
    Model # SP-2411, lot 307850
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-- USA (nationwide) including the states of FL, KY, MN, NJ, SD, and VA., and the country of Australia.
  • Description du dispositif
    Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850***DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com***." || Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04***Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USA***MediMark Europe BP2332 F-38033 Grenoble Cedex 2. France***LOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN***" || Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.
  • 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