Events

Rappel de Tornier AFFINITI Humeral Head

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 Tournier, 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
    50232
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0826-2009
  • Date de mise en oeuvre de l'événement
    2008-10-20
  • Date de publication de l'événement
    2009-01-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-05-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75036
  • 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
    shoulder, prosthesis - Product Code KWS
  • Cause
    Tornier, medical has received a report of a mislabeled sterile affiniti head product. as a result, tornier has decided to voluntarily recall the potentially affected lots, including two (2) lots of affiniti stems.
  • Action
    An Urgent Product Recall letter, dated 10/17/08, was hand delivered to end users by distributors and sales representatives beginning 10/20/08. The recall letter identified the issue and requested end users to immediately discontinue use of the affected products and return any unused affected products to Tornier. Distributors were to notify any and all accounts that may be end users or to provide this information to Tornier, whom will contact the end users. A questionnaire and return instructions were provided with the letter. The questionnaire was asked to be completed and returned to Tornier as soon as possible. For additional information, contact Tornier Customer Service at 1-888-494-7950.

Device

Tornier AFFINITI Humeral Head
  • Modèle / numéro de série
    Lot No.: AA1146C, and AA1438
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    AR, CA, FL, NC, NE, OH, PA, TN, TX, WA, and WI
  • Description du dispositif
    Tornier AFFINITI Humeral Head Standard 44mm x 18mm, Catalog No. 0020045. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.
  • Manufacturer
    Tournier, Inc.

Manufacturer

Tournier, Inc.