Events

Rappel de GENESIS II TIBIAL DRILL 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 Smith & Nephew 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
    55673
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1900-2010
  • Date de mise en oeuvre de l'événement
    2010-04-20
  • Date de publication de l'événement
    2010-06-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91516
  • 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
    Markings for the drill guides are on the incorrect side: left is printed on right side and right is printed on the left side.
  • Action
    All affected Smith & Nephew consignees (International distributors) were notified of problem and the recall via email on 04/20/2010 and an Urgent: Medical Device Recall letter, dated 4/16/2010. The letter stated the reason for the recall and distributors were requested to immediately cease distribution and use of the affected products. They were also asked to examine their stock and stock of their accounts and quarantine any affected product. The Verification Section of the letter should be completed and returned even if there is no affected stock. Anyone the product was distributed to should also be notified and also return the product. Questions should be directed to Kelly Knight at 901-399-5441.

Device

GENESIS II TIBIAL DRILL GUIDE
  • Modèle / numéro de série
    Batch # 08JM07761 and 08JM07761A.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    International Distribution Only -- Belgium, Spain, Germany, Australia, and Brazil.
  • Description du dispositif
    GENESIS II TIBIAL DRILL GUIDE, REF 71440238, SIZE 5, QTY: (1), NON-STERILE, Smith & Nephew, Inc., Memphis, TN 38116, USA || Drill guide used as manual surgical instrument during knee replacement surgeries.
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

Smith & Nephew Inc
  • Adresse du fabricant
    Smith & Nephew Inc, 1450 E. Brooks Rd, Memphis TN 38116
  • Société-mère du fabricant (2017)
    Smith & Nephew plc
  • Source
    USFDA