Events

Rappel de Device Recall Versys Beaded Fullcoat Femoral Stem

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
    65799
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0070-2014
  • Date de mise en oeuvre de l'événement
    2013-08-30
  • Date de publication de l'événement
    2013-10-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-09-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120669
  • 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
    The low density polyethylene (ldpe) bag used to package implants adheres to the highly polished surface of the devices.
  • Action
    August 30, 2013 Urgent Recall Notices were sent to Distributors, hospital risk managers and surgeons identifying the issue and directing consignees to make all affected personnel aware of the contents of the notification. The notice identified the products involved, the issue, possible adverse events associated with the issue and recommended that implants found with LDPE bag adhesion not use the product and return it to Zimmer sales representatives. Questions or concerns should be addressed to Zimmer customer call center at 1-877-946-2761 between the hours of 8 a.m. and 5 p.m. EST.

Device

Device Recall Versys Beaded Fullcoat Femoral Stem
  • Modèle / numéro de série
    Part Number Range: 00-7843-011/022-06/56
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.
  • Description du dispositif
    Versys¿ Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM; VERSYS BEADED FC 11X200MM 8ST; POR FULLCT FEM ST 11 LOW EXT; POR FULLCT FEM ST 11 EXT; POR FLCT FEM STEM LM 11X160MM; POR FULLCT LM FEM ST 11 EXT || POR FULL-CT FEM ST 12X160MM || VERSYS BEADED FC 12X200MM 8 ST || POR FULLCT FEM ST 12 LOW EXT || POR FLCT FEM ST 12.0X190 STR || POR FULLCT FEM ST 12 EXT || POR FULL-CT FEM ST LM 12X160MM || POR FULLCT LM FEM ST 12 EXT || POR FULL-CT FEM ST 13X160MM || VERSYS HIP SYSTEM REVISION FEMORAL BEADED FULLCOAT PLUS COLL || POR FULLCT FEM ST 13 LOW EXT || POR FLCT FEM ST 13.5X190 STR || POR FULLCT FEM ST 13 EXT || POR FULL-CT FEM ST LM 13X160MM || POR FULLCT LM FEM ST 13 EXT || POR FULL-CT FEM ST 14X160MM || VERSYS BEADED FC 14X200MM 8 ST || POR FULLCT FEM ST 14 LOW EXT || POR FULLCT FEM ST 14 EXT || POR FULL-CT FEM ST LM 14X160MM || POR FULLCT LM FEM ST 14 EXT || POR FULL-CT FEM ST 15X160MM || VERSYS BEADED FC 15X200MM 8 ST || POR FULLCT FEM ST 15 LOW EXT || POR FLCT FEM ST 15.0X190 STR || POR FLCT FEM ST 15.0X250 STR || POR FULLCT FEM ST 15 EXT || POR FULL-CT FEM ST LM 15X160MM || POR FULLCT FEM ST 15 XEXT || POR FULLCT LM FEM ST 15 EXT || POR FULL-CT FEM ST 16X160MM || VERSYS BEADED FC 16X200MM 8 ST || POR FULLCT FEM ST 16 LOW EXT || POR FLCT FEM ST 16.5X190 STR || POR FLCT FEM ST 16.5X250 STR || POR FULLCT FEM ST 16 EXT || POR FULL-CT FEM ST LM 16X160MM || POR FULLCT FEM ST 16 XEXT || POR FULLCT LM FEM ST 16 EXT || POR FULL-CT FEM ST 17X160MM || VERSYS BEADED FC 17X200MM 8 ST || POR FULLCT FEM ST 17 EXT || POR FULL-CT FEM ST LM 17X160MM || POR FULLCT FEM ST 17 XEXT || POR FULLCT LM FEM ST 17 EXT || POR FULL-CT FEM ST 18X160MM || VERSYS BEADED FC 18X200MM 8 ST || POR FLCT FEM ST 18.0X190 STR || POR FLCT FEM ST 18.0X250 STR || POR FULLCT FEM ST 18 EXT || POR FULL-CT FEM ST LM 18X160MM || POR FULLCT FEM ST 18 XEXT || POR FULLCT LM FEM ST 18 EXT || POR FULL-CT FEM ST 19X160MM || POR FLCT FEM ST 19.5X190 STR || POR FLCT FEM ST 19.5X250 STR || POR FULLCT FEM ST 19 EXT || POR FLCT FEM STEM LM 19X160MM || POR FULLCT FEM ST 19 XEXT || POR FULLCT LM FEM ST 19 EXT || POR FULL-CT FEM ST 20X160MM || VERSYS BEADED FC 20X200MM 8 ST || POR FULLCT FEM ST 20 EXT || POR FLCT FEM STEM LM 20X160MM || POR FULLCT FEM ST 20 XEXT || POR FULLCT LM FEM ST 20 EXT || POR FULL-CT FEM ST 21X160MM || POR FLCT FEM ST 21.0X190 STR || POR FLCT FEM ST 21.0X250 STR || POR FULLCT FEM ST 21 EXT || POR FLCT FEM STEM LM 21X160MM || POR FULLCT FEM ST 21 XEXT || POR FULLCT LM FEM ST 21 EXT || POR FULLCT FEM STEM 22X160MM || POR FLCT FEM ST 22.5X190 STR || POR FLCT FEM ST 22.5X250 STR || POR FULLCT FEM ST 22 EXT || POR FLCT FEM STEM LM 22X160MM || POR FULLCT FEM ST 22 XEXT || POR FULLCT LM FEM ST 22 EXT. || Used in total hip replacement.
  • 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