Events

Rappel de Device Recall ROIA Anterior Delivery Device

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 LDR Spine USA, 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
    75068
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0045-2017
  • Date de mise en oeuvre de l'événement
    2016-08-29
  • Date de publication de l'événement
    2016-10-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149274
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Cause
    The roi-a anterior delivery device t-handle, part number si-roia-0023 has experienced binding of the rotation of the t-handle. there have been no reports of patient injury.
  • Action
    The firm, LDR, contacted affected consignees via phone and then sent a follow up email dated 9/8/16. The phone script and email described the product, problem and actions to be taken. The consignees were instructed to promptly return the instrument using the RMA#1180. The firm will perform a rework that prevents the binding to occur. If you have any question, contact the Quality Engineering Manager by email: ron.musselman@zimmerbiomet.com, phone: 512-344-3436 or Field Inventory Manager - US Supply Chain or phone: 512-344-3436.

Device

Device Recall ROIA Anterior Delivery Device
  • Modèle / numéro de série
    Lot # 2295101A, 2295101A-R, 2296101A-R
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to states of: GA, OR, FL, KY, NC, AR and PA.
  • Description du dispositif
    ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 || Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
  • Manufacturer
    LDR Spine USA, Inc.

Manufacturer

LDR Spine USA, Inc.
  • Adresse du fabricant
    LDR Spine USA, Inc., 13785 Research Blvd Ste 200, Austin TX 78750-1895
  • 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