Events

Rappel de Device Recall TCPLUS(TM), Primary Fixed Tibial Component VKS

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
    73609
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1538-2016
  • Date de mise en oeuvre de l'événement
    2016-03-11
  • Date de publication de l'événement
    2016-04-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144570
  • 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
    The affected devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (pe) insert on the affected vks tibial base plate during surgery.
  • Action
    The firm, Smith & Nephew, issued an "URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action/Recall" letter dated 3/10/2016 to its local QA/RA personnel/customers in the affected countries by email on 03/11/2016. The letter described the product, problem and actions to be taken. The customers were instructed to locate and quarantine affected unused devices immediately; return quarantined product to your national Smith & Nephew agency/distributor; complete and return the Return Slip via fax to your national Smith & Nephew agency/distributor; and pass on this safety information to all those who need to be aware in your organization. The local QA/RA staff will then notify end customers according to local procedures. In Germany as well as in Switzerland, sales representatives will inform the affected customers in-person and retrieve affected devices from their stock. If you have any questions, call 978-749-1330 or email: joe.metzger@smith-nephew.com

Device

Device Recall TCPLUS(TM), Primary Fixed Tibial Component VKS
  • Modèle / numéro de série
    Batch number C1507158
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    International Distribution only in countries of: Germany and Switzerland.
  • Description du dispositif
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 005, S&N; 7500260, Smith & Nephew Orthopaedics AG || Product Usage: Tibial knee prosthesis
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • Adresse du fabricant
    Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
  • Société-mère du fabricant (2017)
    Smith & Nephew plc
  • Source
    USFDA