Events

Rappel de Device Recall Procotyl (Rim Lock) Liners

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-0685-2017
  • 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=149266
  • 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 Procotyl (Rim Lock) Liners
  • Modèle / numéro de série
    REF PHA04702 Serial Numbers: PHA04702, 087461467, 089909592, 106368684, 106379196, 106381827, 109949208, 129989153, 0201018636, 0301049040   REF PHA04704 Serial Numbers: 010989155, 027373842, 038461468, 057433172, 077453350, 089924904, 106379197, 106380366, 106381751, 0201018637   REF PHA04706 Serial Numbers: 1414640, 010990534, 017400915, 037415861, 039755749, 047420835, 047424536, 077459275, 087461469, 089906466, 0101034747, 106379879, 106381773, 0301084459, 0401100079, 0501122040, 0801189074   REF PHA04708 Serial Numbers: 010990535, 017400568, 037420836, 047424415, 077455537, 087461470, 089901226, 106380367, 106381752, 0311304891, 0401118999, 0601163086, 0711360334   REF PHA04710 Serial Numbers: 1372615, 1413361, 017400673, 037415862, 037420837, 047423789, 047424535, 077457450, 077460608, 089901146, 098695744, 098695746, 106380368, 106381542, 106381753, 108695745, 109944906, 116380977, 119983782, 129990536, 0201016259, 0301076759, 0311303536, 0311305118, 0401089452, 0401121936, 0501131023, 0801187747, 1291000322   REF PHA04712 Serial Numbers: 029695877, 037414678, 047418090, 057426407, 077457328, 098464129, 099906467, 106373846, 106380571, 116389410, 0201058381, 0301084465, 0311303537, 0401117709, 0601163076,  0801188639   REF PHA04714 Serial Numbers: 1414641, 017400569, 029807399, 037415854, 047423790, 077432883, 077445957, 106368690, 0201025145, 0901196483
  • 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
    Procotyl (Rim- Lock) Liners: || REF PHA04702, REF PHA04704, REF PHA04706, REF PHA04708, REF PHA04710, REF PHA04712, REF PHA04714 || For use with the conserve metal head
  • Manufacturer
    MicroPort Orthopedics Inc.

Manufacturer

MicroPort Orthopedics Inc.