Events

Rappel de Standard CoCr Heads

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
    66500
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1034-2014
  • Date de mise en oeuvre de l'événement
    2013-10-11
  • Date de publication de l'événement
    2014-02-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124901
  • 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/polymer, porous uncemented - Product Code LPH
  • Cause
    Zimmer recently conducted a review of all historic packaging validations at its zimmer manufacturing b.V. (zmbv) facility in ponce, puerto rico. based on this review, it was determined that the packaging operations conducted in the building 1 packaging operation at this facility were not properly validated. as a result, zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. the acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. these packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the zmbv facility building 1 packaging operations.
  • Action
    Distributors received a letter identifying the issue and their responsibilities dated November 4, 2013. These responsibilities include quarantining the affected fielded inventory in their possession, providing hospital risk managers with the recall notification letter and retrieving affected fielded inventory and direct sales from the hospitals.

Device

Standard CoCr Heads
  • Modèle / numéro de série
    369934 60308845 60508319 60588077 60670902 60701935 60779840 60790101 60810357 60847644 60906703 61077837 61077838 61191243 61191244 61247015 61304729 61340542 61401735 61485227 61530679 61551614 61555020 61670831 61720512 61774878 61790557 61837158 62025229 62124070 62176438 369935 60339031 60407279 60586160 60658085 60701954 60701967 60779852 60779856 60779863 60806208 60821916 60847645 60900931 61002276 61052833 61077839 61077840 61191246 61304732 61401736 61448090 61502826 61530680 61570271 61618471 61618472 61713710 61734540 61837159 61837160 61896789 62025230 62091051 62176441 62284369 60339030 60392901 60440343 60508338 60656885 60669433 60779864 60779866 60779867 60790102 60806209 60821917 60847646 61002277 61052834 61077841 61144531 61191245 61304736 61401737 61485225 61530678 61551616 61551617 61670830 61713709 61734539 61774872 61779845 61790554 61896791 61896792 62025231 62025232 62124069 62176444 62218172 60323824 60439671 60508340 60536879 60611544 60652728 60684197 60779872 60790103 60847647 60906704 61002278 61077842 61191242 61224848 61304741 61340544 61424894 61485226 61618473 61676503 61713708 61774879 61779846 61790560 61896793 62025233 62093451 62176446 62218173 60439652 60515401 60593679 60701996 60884548 60940020 61018982 61077843 61081687 61191241 61224849 61304743 61459434 61535709 61618470 61683763 61720514 61774871 61779847 61837161 61896795 62025234 62098854 62099285
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.
  • Description du dispositif
    6 DEGREE COCR FEM HEAD 36
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Adresse du fabricant
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 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