Events

Rappel de Device Recall Conserve Shells

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 MicroPort Orthopedics 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
    75063
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0687-2017
  • Date de mise en oeuvre de l'événement
    2016-06-21
  • Date de publication de l'événement
    2016-12-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-07-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149414
  • 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
    Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • Cause
    Revision rate trends from within the microport orthopedics inc. database evaluated for the modular head metal on metal tha systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head conserve(r) systems and dynasty(r) metal acetabular liner systems.
  • Action
    MicroPort sent an Urgent Field Safety Notice dated June 22, 2016, to all affected customers notifying them of the change in the instructions for use on July 7th, 2016 by email. The firm also notified US hospitals where the implantation surgeries occurred within the last twelve (12) months by letter on July 13th, 2016 delivered by FedEx Priority. Customers were asked to complete and return the enclosed form even if they do not have any affected product to return by fax to 1-901-451-6032 or PostMarket@ortho.microport.com. For questions regarding this recall call 901-867-4771.

Device

Device Recall Conserve Shells
  • Modèle / numéro de série
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kingdom, and Vietnam.
  • Description du dispositif
    Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF 38021154, REF 38021156, REF 38021158, REF 38021160, REF 38021162, REF 38021164, REF 38023642, REF 38023646, REF 38023844, REF 38023848, REF 38024046, REF 38024050, REF 38024248, REF 38024252, REF 38024450, REF 38024454, REF 38024652, REF 38024656, REF 38024854, REF 38024858, REF 38025056, REF 38025060, REF 38025258, REF 38025262, REF 38025460, REF 38025464, REF 38025662, REF 38025664, REF 38025666, REF 38025668, REF 38123844, REF 38124046, REF 38124248, REF 38124450, REF 38125056, REF 38125662, REF 38HA3642, REF 38HA3844, REF 38HA4046, REF 38HA4248, REF 38HA4450, REF 38HA4652, REF 38HA4854, REF 38HA5056, REF 38HA5258, REF 38HA5460, REF 38HA5662, REF 38HA5664, REF 38HA5864, REF 38HA6066, REF 38SP3642, REF 38SP3844, REF 38SP4046, REF 38SP4248, REF 38SP4450, REF 38SP4652, REF 38SP4854, REF 38SP5056, REF 38SP5258, REF 38SP5460, REF 38SP5662, REF 38SP5664 || For use with the conserve metal head
  • Manufacturer
    MicroPort Orthopedics Inc.

Manufacturer

MicroPort Orthopedics Inc.