Events

Rappel de Device Recall Novation 12/14 Pressfit Femoral Stem

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
    68341
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2086-2014
  • Date de mise en oeuvre de l'événement
    2014-03-07
  • Date de publication de l'événement
    2014-07-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-08-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127375
  • 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
    The femoral stem is lacking specified plasma coating.
  • Action
    Exactech sent an Important Product Recall Notice dated March 10, 2014, to all affected customers. The notice identified the product the problem and the action to be taken by the customer. Description of Issue: The femoral stem is lacking specified plasma spray coating. Clinical Impact: Without plasma spray coating, the stem may not remain stable and will not have the possibility for biological fixation. In order to comply with applicable regulations and Exactech policies customers were instructed to : " Immediately cease distribution or use of these products. " Extend this information to your accounts that may have this product in their possession. " Determine if they have any of the affected devices " Fax back the attached form. Complete the attached fax back form and return it to Exactech. Customers were instructed to contact their Exactech inventory representative within 5 business days to confirm quantities at their location. For any inventory restocking questions related to this issue, please call 1-800-392-2832. For questions regarding this recall call 800-392-2832.

Device

Device Recall Novation 12/14 Pressfit Femoral Stem
  • Modèle / numéro de série
    Serial Numbers: 2910243, 2910244, 2910245, 2910246, 2910247, 2910248, 2910249, 2910250, 2910251, and 2910252
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution including Spain, Greece and Japan
  • Description du dispositif
    NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 || intended to be implanted to replace a hip joint with our without bone cement.
  • 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