Events

Rappel de Zimmer

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 Trabecular Metal Technology, 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
    73536
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1953-2016
  • Date de mise en oeuvre de l'événement
    2016-04-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-11-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145915
  • 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, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
  • Cause
    Zimmer biomet is initiating a recall of specific lots of foil pouched, sterile trabecular metal implants that were manufactured between april 2011 and october 2012. the foil pouches are part of a dual barrier system to provide sterile integrity.
  • Action
    Zimmer issued an Urgent Medical Device Recall Letter dated 4/15/2016.

Device

Zimmer
  • Modèle / numéro de série
    00588606510 TM MONO TIB STR GRN SZ 5 10MM 61769554 61780786 61803934 00588606512 TM MONO TIB STR GRN SZ 5 12MM 61769555 61785358 00588606514 TM MONO TIB STR GRN SZ 5 14MM 61746710 61769556 61785359 61803935 00588606517 TM MONO TIB STR GRN SZ 5 17MM 61739874 61780787 61785360 61792655 61803936 61809005 00588606610 TM MONO TIB STR GRN SZ 6 10MM 61770839 61780793 61785374 61809020 61820718 61839382 00588606612 TM MONO TIB STR GRN SZ 6 12MM 61739882 61733397 61759778 61770840 61785375 61809018 61844376 00588606614 TM MONO TIB STR GRN SZ 6 14MM 61739885 61759779 61780795 61785376 61809015 00588606617 TM MONO TIB STR GRN SZ 6 17MM 61739883 61785377 61820719 00588606710 TM MONO TIB STR BLUE SZ 7 10MM 61769582 61792678 61797213 61851763 00588606712 TM MONO TIB STR BLUE SZ 7 12MM 61785386 61792681 61797214 61857235 00588606714 TM MONO TIB STR BLUE SZ 7 14MM 61780797 61785387 61809058 00588606717 TM MONO TIB STR BLUE SZ 7 17MM 61785388 61814249 00588607510 TM MONO TIB STR GRN SZ 5 10MM 61785366 61803928 61820713 61844346 00588607512 TM MONO TIB STR GRN SZ 5 12MM 61770823 61792661 61803929 61851753 00588607514 TM MONO TIB STR GRN SZ 5 14MM 61739865 61785369 61803931 00588607517 TM MONO TIB STR GRN SZ 5 17MM 61785370
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide and Foreign.
  • Description du dispositif
    TM MONO TIB STR GRN SZ 5 - 00588606510 || TM MONO TIB STR GRN SZ 5 12MM - 00588606512 || TM MONO TIB STR GRN SZ 5 14MM - 00588606514 || TM MONO TIB STR GRN SZ 5 17MM - 00588606517 || TM MONO TIB STR GRN SZ 6 10MM - 00588606610 || TM MONO TIB STR GRN SZ 6 12MM - 00588606612 || TM MONO TIB STR GRN SZ 6 14MM - 00588606614 || TM MONO TIB STR GRN SZ 6 17MM - 00588606617 || TM MONO TIB STR BLUE SZ 7 10MM - 00588606710 || TM MONO TIB STR BLUE SZ 7 12MM - 00588606712 || TM MONO TIB STR BLUE SZ 7 14MM - 00588606714 || TM MONO TIB STR BLUE SZ 7 17MM - 00588606717 || TM MONO TIB STR GRN SZ 5 10MM - 00588607510 || TM MONO TIB STR GRN SZ 5 12MM - 00588607512 || TM MONO TIB STR GRN SZ 5 14MM - 00588607514 || TM MONO TIB STR GRN SZ 5 17MM - 00588607517
  • Manufacturer
    Zimmer Trabecular Metal Technology, Inc.

Manufacturer

Zimmer Trabecular Metal Technology, Inc.
  • Adresse du fabricant
    Zimmer Trabecular Metal Technology, Inc., 10 Pomeroy Rd, Parsippany NJ 07054-3722
  • 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