Events

Rappel de Device Recall Triathlon Femoral Distal Augment Left

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
    64941
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1370-2013
  • Date de mise en oeuvre de l'événement
    2013-03-25
  • Date de publication de l'événement
    2013-05-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-05-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117473
  • 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
    Stryker orthopaedics received a report that a label on the external packaging (box) of a triathalon femoral distal augment 10mm- size 5 left depicted a glyph of an acetabular shell rather than a femoral distal augment. in addition the label was missing a reference to the "10mm" augment thickness which per the label print is required to appear below the size reference.
  • Action
    The firm, Stryker Orthopaedics, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated March 25, 2013 and Product Accountability Forms via Fed Ex to its Consignees/ customers. The letter described the product, problem and actions to be taken. The customers were instructed to complete and return the attached Notification Acknowledgment Form within 5 days via fax to 855-251-3635; contact the hospitals in your territory that have the affected product to arrange return of product; and return affected product to the attention of Regulatory Compliance Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430, attach flourescent orange PRODUCT REMEDIATION sticker to your return indicating the PR #RA2013-011 and mark outer box with the words "Product Recall". If you have any questions, feel free to contact Manager, Divisional Regulatory Compliance at (201) 972-2100.

Device

Device Recall Triathlon Femoral Distal Augment Left
  • Modèle / numéro de série
    Catalog Number 5541-A-501 Lot Codes HALY, HAOO, HANG
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide distribution: USA including states of: HI, IN, MS, NC, NJ, OK, TX, and WI.
  • Description du dispositif
    Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package || Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA || Stryker France, ZAC Satolas Green Pusignan, Av de Satoles Green 69881 || Meyzieu, Cedex, France || This device is used when there is a deficiency in the bone present during femoral preparation these devices are used to "fill the gap" between the implant and the bone
  • 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