Events

Rappel de Device Recall Zimmer Plates and Screws

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 Manufacturing B.V..

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
    73981
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1677-2016
  • Date de mise en oeuvre de l'événement
    2016-05-04
  • Date de publication de l'événement
    2016-05-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-07-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145971
  • 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
    Screw, fixation, bone - Product Code HWC
  • Cause
    A small hole may be present in the inner tray of specific lots of sterile hip and trauma implant screws.
  • Action
    All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.

Device

Device Recall Zimmer Plates and Screws
  • Modèle / numéro de série
    LOTS: 63303573 63282072 63303577 63303574 63296633 63295456 63296634 63198636 63295464 63296636 63296638 63301486 63301487 63301489 63296639 63248519 63298802 63298803 63287869 63248522 63317364 63317363 63248525 63298795 63320881 63287871 63317168 63248527 63317167 63287874 63248531 63248532 63248535 63248537 63293690 63293693 63293694 63305250 63298784 63284871 63298783 63249226 63305251 63312141
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
  • Description du dispositif
    Zimmer Plates and Screws (ZPS) || 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 || 4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 47484001400 || 4.0 mm Cancellous Screw Fully Threaded, 16 mm Length 47484001600 || 4.0 mm Cancellous Screw Fully Threaded, 18 mm Length 47484001800 || 4.0 mm Cancellous Screw Fully Threaded, 20 mm Length 47484002000 || 4.0 mm Cancellous Scrwe Fully Threaded, 22 mm Length 47484002200 || 4.0 mm Cancellous Screw Fully Threaded, 26 mm Length 47484002600 || 4.0 mm Cancellous Screw Fully Threaded, 30 mm Length 47484003001 || 4.0 mm Cancellous Screw Fully Threaded, 32 mm Length 47484003200 || 4.0 mm Cancellous Screw Fully Threaded, 36 mm Length 47484003600 || 4.0 mm Cancellous Screw Fully Threaded, 40 mm Length 47484004000 || 4.0 mm Cancellous Screw Fully Threaded, 45 mm Length 47484004500 || 4.0 mm Cancellous Screw Fully Threaded, 50 mm Length 47484005000 || 4.0 mm Cancellous Screw Fully Threaded, 55 mm Length 47484005500 || 4.0 mm Cancellous Screw Fully Threaded, 60 mm Length 47484006000 || 4.5 mm Cortical Screw SelfTapping, 16 mm Length 47484501601 || 4.5 mm Cortical Screw SelfTapping, 18 mm Length 47484501801 || 4.5 mm Cortical Screw Self-Tapping, 20 mm Length 47484502001 || 4.5 mm Cortical Screw Self-Tapping, 22 mm Length 47484502201 || 4.5 mm Cortical Screw SelfTapping, 24 mm Length 47484502401 || 4.5 mm Cortical Screw SelfTapping, 26 mm Length 47484502601 || 4.5 mm Cortical Screw SelfTapping, 28 mm Length 47484502801 || 4.5 mm Cortical Screw SelfTapping, 34 mm Length 47484503401 || 4.5 mm Cortical Screw SelfTapping, 38 mm Length 47484503801 || 4.5 mm Cortical Screw SelfTapping, 40 mm Length 47484504001 || 4.5 mm Cortical Screw SelfTapping, 42 mm Length 47484504201 || 4.5 mm Cortical Screw SelfTapping, 54 mm Length 47484505401 || 4.5 mm Cortical Screw Self-Tapping, 58 mm Length 47484505801 || 4.5 mm Cortical Screw SelfTapping, 64 mm Length 47484506401 || 4.5 mm Cortical Screw SelfTapping, 66 mm Length 47484506601 || 4.5 mm Cortical Screw SelfTapping, 68 mm Length 47484506801 || 4.5 mm Cortical Screw SelfTapping, 70 mm Length 47484507001 || 6.5 mm Cancellous Screw Fully Threaded, 45 mm Length 47486504500 || 6.5 mm Cancellous Screw Fully Threaded, 55 mm Length 47486505500 || 6.5 mm Cancellous Screw Fully Threaded, 60 mm Length 47486506000 || 6.5 mm Cancellous Screw, 32 mm Thread Length, 60 mm Length 47486506002 || 6.5 mm Cancellous Screw Fully Threaded, 65 mm Length 47486506500 || 6.5 mm Cancellous Screw, 32 mm Thread Length, 65 mm Length 47486506502 || 6.5 mm Cancellous Screw Fully Threaded, 70 mm Length 47486507000 || 6.5 mm Cancellous Screw, 16 mm Thread Length, 80 mm Length 47486508001 || 6.5 mm Cancellous Screw, 32 mm Thread Length, 80 mm Length 47486508002 || 6.5 mm Cancellous Screw, 32 mm Thread Length, 85 mm Length 47486508502
  • Manufacturer
    Zimmer Manufacturing B.V.

Manufacturer

Zimmer Manufacturing B.V.
  • Adresse du fabricant
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • 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