Events

Rappel de Device Recall Interventional Pain 6" 13 G (2.4 mm) Percutaneous Discectomy Probe, REF 407265,

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 Stryker Instruments Division of Stryker Corporation.

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
    57899
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1829-2011
  • Date de mise en oeuvre de l'événement
    2011-02-03
  • Date de publication de l'événement
    2011-03-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-06-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97707
  • 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
    Arthroscope - Product Code HRX
  • Cause
    The firm received five complaints that the stylet did not fit down the cannula. the investigation revealed that the incorrect probe assembly was packaged for two dekompressor part numbers with the lot number of 10214012.
  • Action
    Stryker Instruments Division of Stryker Corporation sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated February 3, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their inventory for any recalled product and quarantine any affected product. If the product was further distributed, customers were asked to forward the letter and the completed Reply Form to all affected locations. Customers were to be contacted to coordinate return of the affected product. Upon receipt of the product, a replacement would be issued to their account. For questions regarding this recall call 1-800-253-3210.

Device

Device Recall Interventional Pain 6" 13 G (2.4 mm) Percutaneous Discectomy Probe, REF 407265,
  • Modèle / numéro de série
    Lot: 10214012.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including the states of PA, NY, KS, NJ, TX, MI, OK, and FL, and the countries of Italy and Switzerland.
  • Description du dispositif
    Interventional Pain 6" 13 G (2.4 mm) Percutaneous Discectomy Probe, REF 407-265, Sterile, Stryker Instruments, Kalamazoo, MI. || The DeKompressor Percutaneous Discectomy Probe is intended for use in the apiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine
  • Manufacturer
    Stryker Instruments Division of Stryker Corporation

Manufacturer

Stryker Instruments Division of Stryker Corporation
  • Adresse du fabricant
    Stryker Instruments Division of Stryker Corporation, 4100 East Milham Ave., Kalamazoo MI 49001
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA