Events

Rappel de Device Recall THINFLAP SYSTEM CROSSDRIVE, SELFDRILLING SCREW 1.5X4MM (.059X.159") (WXL)TITANIUM

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
    59002
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2873-2011
  • Date de mise en oeuvre de l'événement
    2010-05-17
  • Date de publication de l'événement
    2011-07-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-10-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100808
  • 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
    On may 17, 2010, biomet microfixation issued a safety alert on their thinflap system cross drive, self drilling screw, 1.5x4mm, model #: 91-6704, lot#: 173770. the product is labeled incorrectly. some packages of 91-6704 lot 173770 are labeled as cross drive screws, but contain center drive screws. all affected customers were notified of the recall on may 17, 2010.
  • Action
    Biomet Microfixation notified distributors and customers by letter, email and telephone calls. Distributors and customers were instructed to fill out and return the Inventory Reconciliation sheet, via Fax to 904-741-9425. Distributors were also instructed to notify their customers if the product was distributed further. For questions regarding this recall customers were instructed to call 1-800-874-7711 or 904-741-4400, ext. 468.

Device

Device Recall THINFLAP SYSTEM CROSSDRIVE, SELFDRILLING SCREW 1.5X4MM (.059X.159") (WXL)TITANIUM
  • Modèle / numéro de série
    Lot 173770
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA including AL, CA, GA, HI, IL, MO, NC, NY, TX and the country of Japan.
  • Description du dispositif
    "***REF: 91-6704***THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM (.059X.159") (WXL)***TITANIUM***NON-STERILE PRODUCT***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA*** www.biometmicrofixation.com***QTY 00001***". || Internal fixation screws intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal 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