Events

Rappel de Device Recall Stryker PCD Precision System 13G Needle with Spineplex

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 Div. 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
    60586
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0862-2012
  • Date de mise en oeuvre de l'événement
    2011-11-30
  • Date de publication de l'événement
    2012-01-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105884
  • 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
    Mixer, cement, for clinical use - Product Code JDZ
  • Cause
    Product was packaged with a four inch needle in stead of the correct five inch needle. there is a potential that the needle may not be able to reach the fracture site, which may require additional medical intervention. in addition, if the stylet needs to be changed and the additional stylet that comes in the package is used, this additional stylet is one inch longer than the needle. which could l.
  • Action
    Stryker sent an Urgent Recall Notification letter dated December 7, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. If product was further distributed, customers should forward the recall notification letter and the attached Business Reply Form (BRF) to all affected locations. Immediately check inventory and quarantine any affected product found. Mark product as "RECALLED PRODUCT". Indicate on the BRF the quantity of affected PCD kits they are returning and fill in the form completely. Fax the Business Reply Form to Stryker Instruments Regulatory Department, 866-521-2762. Upon receipt of the BRF, Stryker will contact them to coordinate the return of all affected product that they have on hand. For questions regarding this recall call 269-389-4354. .

Device

Device Recall Stryker PCD Precision System 13G Needle with Spineplex
  • Modèle / numéro de série
    Part Number 0505-585-000, Lot 11223012  13G Match Ground Four facet Tip Introduction Needle - PIN 0306-130-011 13G Bevel Tip Stylet - PIN 0306-131-012
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including FL, PA, NY, OH, IL, KY, MT, WA, CA, MO, HI, IN, SC, MS, WV, KS, TX, and WY
  • Description du dispositif
    Stryker PCD Precision System 13G Needle with Spineplex, sterile, single use, disposable , 4 units per box. units per box. Stryker Instruments, Kalamazoo, MI || Part Number: 0505-585-000, Lot:11223012 || 13G Match Ground Four facet Tip Introduction Needle - PIN 0306-130-011 || 13G Bevel Tip Stylet - PIN 0306-131-012 || The intended use of the Stryker PCD System is for mixing bone cement and delivering it percutaneously. Bone cement is mixed in the chamber then transferred directly into an extension nozzle which has been attached to the introduction needle in the fracture site by a luer lock fitting. Cement is then dispensed directly into the fracture site under fluoroscopy
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Adresse du fabricant
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA