Events

Rappel de Device Recall Femoral Stems

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 Exactech, 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
    74317
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2128-2016
  • Date de mise en oeuvre de l'événement
    2016-05-26
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147140
  • 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, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • Cause
    Labeled with the incorrect global trade item number (gtin). the gtin on the label identifies the devices as another.
  • Action
    Exatech sent an Important Notification letter dated May 16, 2016, to all affected customers. The letter notified customers of the product's incorrect Global Trade Item Number. Customers were instructed to cease distribution/use of the product, extend the information to accounts possessing the recalled product, identify and quarantine any devices in inventory, and to complete and return the Recall Inventory Response Form acknowledging that they received the recall notification. Customers were instructed to call 800-392-2832 with any questions. For questions regarding this recall call 352-377-1140.

Device

Device Recall Femoral Stems
  • Modèle / numéro de série
    Catalog #: 160-33-18; Serial#: 4300062, 4300063; Exp Date: 02/27/2021. Catalog #: 160-33-18; Serial#:4325742, 4325743, 4325744, 4325745, 4325746, 4325747, 4325748, 4325749, 4325750, 4325751, 4325752, 4325753; Exp Date: 03/17/2021.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribuiton to OK, ME, NY, & Hawaii.
  • Description du dispositif
    Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18. || Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and proximal femoral fractures. Also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Intended for press-fit fixation.
  • Manufacturer
    Exactech, Inc.

Manufacturer

Exactech, Inc.
  • Adresse du fabricant
    Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
  • Société-mère du fabricant (2017)
    Exactech Inc
  • Source
    USFDA