Events

Rappel de Device Recall Biomet Spine Polaris Spinal System

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 Spine, LLC.

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
    70961
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2152-2015
  • Date de mise en oeuvre de l'événement
    2015-03-12
  • Date de publication de l'événement
    2015-07-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-12-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135736
  • 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
    Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
  • Cause
    Multiaxial screws may not meet internal requirements related to fatigue strength. compression testing result and surface treatment are out of specification.
  • Action
    Biomet Spine issued an Urgent Medical Device Recall Notice/Response Form dated 3/12/2015 to their affected customers.

Device

Device Recall Biomet Spine Polaris Spinal System
  • Modèle / numéro de série
    Part Numbers: 14-582020, 14-582022, 14-582025, 14-582030, 14-582035, 14-582040, 14-582120, 14-582122, 14-582125, 14-582127, 14-582130, 14-582135, 14-582140, 14-582220, 14-582222, 14-582225, 14-582230, 14-582235, 14-582240, 14-582245, 14-582250, 14-592320, 14-582325, 14-582330, 14-582335, 14-582340, 14-582345, 14-582350, 14-582530, 14-582535, 14-582540, 14-582545, 14-582550, 14-582565, 14-582570, 14-582575, 14-583020, 14-583025, 14-583030, 14-583035, 14-583040, 14-583120, 14-583125, 14-583130, 14-583135, 14-583140, 14-583220, 14-583225, 14-583230, 14-583235, 14-583240, 14-583245, 14-583250, 14-583320, 14-583325, 14-583330, 14-583335, 14-583340, 14-583345 and 14-583350. All lots.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distribution US Nationwide (AL, CA, CO, FL, GA, LA, MA, MD, MI, MO, NY, OH, PA, TX, WA, WI) and The Netherlands.
  • Description du dispositif
    Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF 14-583020, Biomet Spine and Bone Healing Technologies. Spinal fixation component.
  • Manufacturer
    Biomet Spine, LLC

Manufacturer

Biomet Spine, LLC
  • Adresse du fabricant
    Biomet Spine, LLC, 399 Jefferson Rd, Parsippany NJ 07054-3707
  • 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