Events

Rappel de Device Recall STAFlex SUBTALAR SCREW

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
    57831
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1613-2011
  • Date de mise en oeuvre de l'événement
    2011-01-21
  • Date de publication de l'événement
    2011-03-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-11-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97597
  • 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
    Bone Fixation Screw - Product Code HWC
  • Cause
    The firm has initiated this recall following internal fatigue testing that shows possible initiation of fatigue cracking in implants under load.
  • Action
    The firm sent URGENT MEDICAL DEVICE RECALL NOTICES dated 1/21/2011 to distributors, implanting physicians, and medical facilities. The letter to the distributors and medical facilities states the recalled product should be immediately located and returned to Biomet. In addition, the "FAX Back Response Form" should be completed and returned to the number provided. If product has been further distributed, distributors are to contact hospital personnel via the enclosed "Dear Biomet Customer" notice. The letter to the implanting physicians informs the physician of the recall and lists the patients that were implanted with the device. The physician letter quotes from the surgical technique "the implant should also be removed if any postoperative complications occur". The letter to the implanting physicians does not recommend any action be taken with the devices that are implanted. The notice just makes the surgeons aware of the recall. Distributors and Physicians are to confirm receipt of the letter by contacting 800-348-9500, ext 3755 or 3756. Also, questions related to this matter should be directed to 574-371-3755 or 574-371-3756.

Device

Device Recall STAFlex SUBTALAR SCREW
  • Modèle / numéro de série
    Lot Numbers: 879260, 890850, and 894180.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    STA-Flex SUBTALAR SCREW, 8 mm x 14 mm, REF 982362, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN. || Used to reduce excessive rearfoot pronation by blocking forward and downward displacement of the Talus, resulting in improved rearfoot alignment and foot function.
  • Manufacturer
    Biomet, Inc.

Manufacturer

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