Events

Rappel de Device Recall Micromax Anchors

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
    61104
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1233-2012
  • Date de mise en oeuvre de l'événement
    2012-01-25
  • Date de publication de l'événement
    2012-03-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-04-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107723
  • 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
    Screw, fixation, bone - Product Code HWC
  • Cause
    Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072). this meant that the indications, contraindications, possible adverse effects, and some warnings are not present with the packaged device.
  • Action
    Biomed Inc. sent an Urgent Medical Device Recall Notice dated January 25, 2012 to distributors, hospitals, and OR managers via US mail. The notice identified the product, description of problem, possible adverse health consequences, and actions to be taken, including directions to immediately locate devices and stop device use ,with directions for return. A copy of the correct package insert was included with directions to report any procedures performed outside of indications for use. Receipt confirmation was requested by calling 800-348-9500, extension 3983 or 3009. The notice included a list of units invoiced to the account with a FaxBack Response form to be filled out and sent to the Attention of Angie Dickson, Biomet, 56 East Bell Drive Warsaw, In 46580. Questions concerning the recall should be directed to 574-371-3983 or 574-371-3009, M-F 8-5PM(EST)

Device

Device Recall Micromax Anchors
  • Modèle / numéro de série
    006500, 072300, 130540, 352960, 352970, 379540, 379550, 435430, 450680, 463730, 463740, 463750, 463760, 464260, 464270, 464280, 520700, 520710, 573090, 756020, 902250
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Brazil, Chile, Colombia, Israel, Mexico and Netherlands.
  • Description du dispositif
    REF 905571, 5.5 mm Lactoscrew Anchors,WITH Needles #2 Maxbraid (Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN || Product Usage: The Biomet Sports Medicine Soft Tissue Anchoring Devices are resorbable repair devices used to attach soft tissue to bone.
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Adresse du fabricant
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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