Events

Rappel de Device Recall Stryker Orthobiologics Aliquot Syringe Delivery System, 6", Part Number 20900504

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 Orthovita, Inc., dBA Stryker Orthobiologics..

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
    63204
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1390-2013
  • Date de mise en oeuvre de l'événement
    2012-11-10
  • Date de publication de l'événement
    2013-05-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-10-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115052
  • 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
    Injector, vertebroplasty (does not contain cement) - Product Code OAR
  • Cause
    There have been a few reported cases of the catheter breaking when removing the aliquot catheter from the needle during vertebroplasty procedures. this has been attributed to bending of the catheter during the retraction from the needle. it was determined to be use errors. the correction is limited to a revision of the directions for use.
  • Action
    Stryker sent an Urgent Medical Device Correction letter dated November 10, 2012 to all affected customers. The letter identified the affected product, problem issue, potential hazards and actions to be taken. Customers were instructed to immediately review this notification and the attached IFU. Customers were asked to complete and sign the enclosed Business Reply Form and fax a copy to 1-484-323-8803. For questions contact Stryker Orthobiologics.

Device

Device Recall Stryker Orthobiologics Aliquot Syringe Delivery System, 6", Part Number 20900504
  • Modèle / numéro de série
    Manufacturer Part Number 2090-0504, Lot Numbers A1006026 and A1111020
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
  • Description du dispositif
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6", Part Number 2090-0504 || Product Usage: || Facilitate placement of bone cement in weakened or diminished bone
  • Manufacturer
    Orthovita, Inc., dBA Stryker Orthobiologics.

Manufacturer

Orthovita, Inc., dBA Stryker Orthobiologics.
  • Adresse du fabricant
    Orthovita, Inc., dBA Stryker Orthobiologics., 45 Great Valley Pkwy, Malvern PA 19355-1302
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA