Events

Rappel de Device Recall Reflection Interfit Shell, 52 MM OD, 3 HOLE

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
    67404
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1066-2014
  • Date de mise en oeuvre de l'événement
    2014-01-23
  • Date de publication de l'événement
    2014-02-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-11-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125406
  • 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, hip, semi-constrained, uncemented, metal/polymer, porous - Product Code MBL
  • Cause
    Inner spherical radius of the shell is undersized.
  • Action
    Smith & Nephew Inc. sent an Urgent - Product Recall 1st Notification letter dated January 23, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Actions for Hospital Representatives: 1. Please inspect your inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. 2. Complete the last two columns in the Inventory Return Certification Form on the following page, indicating the quantities that need to be returned, and include your phone and fax number in the spaces provided. If you do not have product to return, please place an x in the column No product to return. 3. Please contact Smith & Nephews Safety Affairs Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to obtain a return authorization (RA) number. 4. Return any affected product to the address listed on the Inventory Return Certification Form. Please indicate the RA number on your return shipment. Actions for Smith & Nephew Inventory Specialists 1. Please inspect your inventory and locate any unused devices from the above listed product and batch numbers, cease distribution and use of those products, and quarantine them immediately. 2. Carry out a physical count of all affected product in your territory and record this data on the Inventory Return Certification Form on the following page. 3. If you do not have product to return, please place an x in the column No Product to Return, and then fill in the Acknowledgement of Responsibility at the bottom of the form. 4. Fax a copy of the completed Inventory Return Certification Form to: +1-901-566-7975 5. If you have affected products, return the product, along with the completed Inventory Return Certification Form, to the address indicated

Device

Device Recall Reflection Interfit Shell, 52 MM OD, 3 HOLE
  • Modèle / numéro de série
    Batch No. 13EM03053
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution: US Distribution to NJ and FL; and the countries of: Colombia and Costa Rica.
  • Description du dispositif
    Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. || Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post traumatic arthritis, avascular necrosis; femoral and neck fractures; osteomyelitis; fracture, dislocation of the hip; and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection.
  • 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