Events

Rappel de Uniflex Humeral Nail

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 Zimmer 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
    75229
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0087-2017
  • Date de mise en oeuvre de l'événement
    2016-08-02
  • Date de publication de l'événement
    2016-10-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149723
  • 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
    Pin, fixation, smooth - Product Code HTY
  • Cause
    The g-pin 2.8bl 3.2pl 60 cm 2pk is intended to contain one (1) 467265-01 ball tip guide pin and one (1) 467255-02 plain tip guide pin. the g-pin 2.8bl 3.2pl 60 cm 2pk may have been packaged incorrectly either with two (2) 467265-01 ball tip guide pins and zero (0) 467255-02 plain tip guide pins or with zero (0) 467265-01 ball tip guide pins and two (2) 467255-02 plain tip guide pins. if the g-pin 2.8bl 3.2pl 60 cm 2pk contains the incorrect combination of plain tip guide pins and ball tip guide pins, the surgeon would either have to implant the nail without the plain tip guide pin as a guide, ream with a plain tip guide pin, or choose to not ream the humeral canal. the risk associated with not having the correct combination can include a delay in surgery of less than 30 minutes, the reamer tip remaining in the distal humeral canal, or an iatrogenic fracture.
  • Action
    The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL REMOVAL" notification dated 8/2/2016 affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The consignees were instructed to review the notification and ensure affected team members are aware of the contents; immediately locate and quarantine affected product in your inventory; complete and return the Certification of Acknowledgment portion of Attachment-1 Inventory Return Certification Form via digital copy within three (3) days via email to CPWARFieldAction@zimmerbiomet.com or via fax to 574-372-1683; Immediately return all affected product from your distributorship and affected hospitals within your territory; and retain a copy of your recall acknowledgement and product return form. If after reviewing this notice you have further questions or concerns please call 1-800-348-9500 ext. 1251 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of business hours will receive a prompt to record a voicemail and will be returned upon receipt. Alternatively, your questions may be sent by email to CPWARFieldAction@zimmerbiomet.com.

Device

Uniflex Humeral Nail
  • Modèle / numéro de série
    Item Number 467265 Lot Number 662420
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution to states of: MD,TX, FL, GA, VA and PA.
  • Description du dispositif
    Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK || Pin, Fixation, Smooth || A 467265-01 Ball Tip Guide Pin is used to guide reamers down the humeral canal during a Uniflex Humeral Nail procedure. A 467255-02 Plain Guide Pin is used to guide a Uniflex Humeral Nail implant into the humeral canal after the fracture has been reduced.
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Adresse du fabricant
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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