Events

Rappel de Device Recall Versafitcup Double Mobility Liner Inserter

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 Medacta Usa 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
    59043
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2709-2011
  • Date de mise en oeuvre de l'événement
    2011-05-23
  • Date de publication de l'événement
    2011-06-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-07-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100899
  • 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
    Prothesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calcium-phosphate - Product Code MEH
  • Cause
    Medacta international has recently realized that the base of the liner inserter ref 01.26.10.0018 lot 105549 of the versafitcup double mobility system could become rusty after the washing procedures. this is due to an incorrect raw material used by one of our suppliers during the production phase of this lot. for this reason, medacta international has made the decision to remove all the pieces.
  • Action
    Medacta USA sent an "URGENT SAFETY NOTIFICATION-VERSAFITCUP DM LINER INSERTER" letter dated May 23, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory for the affected device, immediately sequester it and not use the device in surgery. The letter instructs customers to pack the affected device for shipment to Medacta USA under Return Material Authorization 1590. Customer will receive a replacement within a few days. Questions regarding this recall are directed to the Director of Regulatory and Quality at 805-437-7085 ext. 26.

Device

Device Recall Versafitcup Double Mobility Liner Inserter
  • Modèle / numéro de série
    Lot code: 105549
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution--USA (nationwide) including the states of CA, ID, IL, and OH, and 9 products to foreign countries.
  • Description du dispositif
    Product Brand Name: Versafitcup Double Mobility Liner Inserter || Product Generic Name: Versafitcup Double Mobility Liner Inserter || Model Number: 01.26.10.0018 || The hip prosthesis is designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature. The patients condition should be due to one or more of: " Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriactic arthritis, Congenital hip dysplasia, Ankylosing spondylitis. " Avascular necrosis of the femoral head. " Acute traumatic fracture of the femoral head or neck. " Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present. " Dislocation risks.
  • Manufacturer
    Medacta Usa Inc

Manufacturer

Medacta Usa Inc
  • Adresse du fabricant
    Medacta Usa Inc, 4725 Calle Quetzal Ste B, Camarillo CA 93012-8429
  • Société-mère du fabricant (2017)
    Medacta Holding Sa
  • Source
    USFDA