Events

Rappel de Persona

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, 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
    68878
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2580-2014
  • Date de mise en oeuvre de l'événement
    2014-08-07
  • Date de publication de l'événement
    2014-09-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-01-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129221
  • 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, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Cause
    Reports of breakage of the persona knee trial articular surface provisionals (tasps). the persona primary knee surgical technique has been updated. this field action correction is to ensure that all distributors and users of this instrument are aware of the enhanced surgical techniques.
  • Action
    On 8/7/2014, Zimmer notified all distributors via electronic mail. Distributors that have received affected inventory are also notified via courier. Hospital risk managers and surgeons are also notified via courier. Hospital risk managers and surgeons were provided with a notification identifying the issue and their responsibilities. These responsibilities include ensuring the affected personnel are aware of the contents of the notification. Distributors were sent a notification identifying the issue and to provide a copy of the notification sent to surgeons and risk managers. The distributors will also be instructed as needed to assist with identifying a comprehensive list of surgeons.

Device

Persona
  • Modèle / numéro de série
    Part Numbers: 42517200410, 42517200510, 42517200610, 42517200710, 42527200410, 42527200510, 42527200610, and 42527200710. Lot numbers:62034570, 62117742, 62156315, 62187322, 62247350, 62314721, 62372409, 62381836, 62397160, 62429190, 62474906, 62551390, 62565048, 62595853, 62614781, 62700416, 62702297, 62724349, 62043548, 62055681, 62104368, 62117743, 62144794, 62165545, 62177246, 62256282, 62351288, 62356244, 62391228, 62427419, 62456268, 62506003, 62551338, 62564355, 62597762, 62614786, 62702292, 62705808, 62717332, 62055682, 62068376, 62068378, 62144795, 62152727, 62187323, 62256283, 62351289, 62356275, 62386419, 62445931, 62456266, 62558584, 62575757, 62611087, 62638672, 62698749, 62736074, 62736075, 62330130, 62563854, 62567418, 62622596, 62070845, 62102088, 62130979, 62149717, 62200303, 62240485, 62256293, 62351304, 62356605, 62391239, 62420238, 62469444, 62551099, 62581081, 62597792, 62627223, 62696849, 62715617, 62059519, 62072593, 62103263, 62110051, 62196614, 62198205, 62248171, 62351307, 62385105, 62401423, 62468266, 62558588, 62595866, 62690052, 62715613, 62072225, 62103266, 62144798, 62156319, 62209049, 62229728, 62282887, 62315140, 62356622, 62386430, 62401427, 62427062, 62428459, 62505998, 62565073, 62581864, 62627283, 62690948, 62696884, 62717330, 62398030, 62428342, 62444343, 62510048, 62515508, 62516058, and 62600154.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY; and countries of: AUSTRALIA, INDIA, JAPAN, KOREA, SINGAPORE, AUSTRIA, BELGIUM, FRANCE, GERMANY, ISRAEL, ITALY, LUXEMBOURG, NETHERLANDS, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWITZERLAND, UNITED KINGDOM, and UNITED ARAB EMIRATES.
  • Description du dispositif
    PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top; Left Size 4-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Right Size 3-7 CD Top; Right Size 4-11 EF Top; Right Size 7-12 GH Top; and Right Size 9-12 J Top.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Adresse du fabricant
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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