Events

Rappel de Scorpio Adjustable Femoral A/P Sizing Guide

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 Stryker Howmedica Osteonics Corp..

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
    56931
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0927-2011
  • Date de publication de l'événement
    2011-01-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95002
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Cause
    Stryker orthopaedics has become aware that there is a potential for the shoulder screw on the scorpio sizing guide (the "sizing guide") to disassociate from the main body of the instrument.
  • Action
    Stryker Orthopaedics sent an 'Urgent Update Product Recall' letter dated December 30, 2010, along with Product Acknowledgement forms to all customers (US and international). The letter described the product, problem and action to be taken by the customers. The customers were asked to complete and return the PRODUCT RECALL ACKNOWLEDGMENT FORM within five (5) days via fax at 201-831-6069; contact the hospitals in their territory that have the affected product to arrange return of the product; and return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100 or the Associate Product Manager, Knee Marketing Team, at (201) 831-5028.

Device

Scorpio Adjustable Femoral A/P Sizing Guide
  • Modèle / numéro de série
    Catalog Number 8000-0313  Lot numbers: RD2M081 RD2MO80 RD2N006 RD2N006E RD2L054 RD2M080E RD2S005X1 RD2S005 RD2S060 RD2N006S RD2S060S RD2S059 RD2V064 RD2V063 RD2V067 RD2V068 RD2V067A RD2V064E RD2V068S RD3A027 RD3A027M RD2V067M RD3A011 RD3A010 RD3A010A RD2VO68M RD3A011H RD3A009 RD2V068H RD3A027H RDA070H RD3A069 RD3A069H RD3A070 RD3L033 RD3N205 RD3N205X1 RD3S020 RD3S094 RD3V086
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and countries including: Australia, Brazil, China, Columbia, France, Greece, India, Italy, Korea, Poland, Singapore, South Africa, and United Kingdom.
  • Description du dispositif
    Scorpio Adjustable Femoral A/P Sizing Guide Assembly; || non-sterile instruments; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; A subsidiary of Stryker Corporation || The A/P sizer is designed to set the desired external rotation and to provide adjustment of the anterior/posterior position when needed.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Adresse du fabricant
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA