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 2
  • 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
    Screw, fixation, bone - Product Code HWC
  • Cause
    Biomet microfixation is recalling lactosorb self drilling adjustable tap model numbers 915-2075 lot # 064350 and 915-2185 lot # 885580. the two lots identified have a new style stop and an old style tap; they are not compatible, as the depth etchings do not line up correctly. depending on the tap (1.5mm vs 2.0mm) you may drill too shallow or too deep.
  • Action
    Biomet Microfixation notified consignees of the recalled product beginning September 2009 via telephone and e-mail correspondence. Users were asked to return the affected product to the firm. For further information, contact Biomet Microfixation at 1-904-741-9468.


  • Modèle / numéro de série
    Lot Number: 064350
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    USA - FL, MO, and KS; Foreign: Brazil and China.
  • Description du dispositif
    LACTOSORB SYSTEM 2.0MM ADJUSTABLE SELF-DRILLING TAP, REF: 915-2075, NON-STERILE PRODUCT, || BIOMET MICROFIXATION,K INC. 1520 TRA DEPORT DRIVE JACKSONVILLE, FL 32218 USA. www.biometmicrofixation.com. || Lacto Sorb Self Drilling Taps are used to drill and tap holes. They are self drilling so they do not require a hole to be drilled prior to use. They are used along with the Lacto SorbBulbs Handles or Power Drivers to advance the Tap into the bone.
  • 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