Events

Rappel de Device Recall Hummer IV Microdebrider System

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
    67775
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1247-2014
  • Date de mise en oeuvre de l'événement
    2014-03-18
  • Date de publication de l'événement
    2014-03-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-05-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126273
  • 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
    Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
  • Cause
    Stryker instruments is voluntarily recalling the single use 2.5mm aggressive blade because the line on the affected part (p/n 5290-928-000, lot #13280cg2) was a straight line without a number scale or logo. the line required for this part number includes a number scale that goes from 1cm  7cm.
  • Action
    Stryker Instruments sent an Recall Notification dated March 18, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed if you have further distributed this product, please forward this letter and the attached Business Reply Form (BRF)to all affected locations. Please indicate each location on the BRF. A FedEx shipping label will be emailed to each account upon receipt of the signed Business Reply Form. This label will allow the account to return the product to be destroyed. A Business Reply Form will be included in each mailing. Return of this form will serve as confirmation that the account has received the notification and executed the recall. Follow up phone calls, emails, and faxes will be sent to non-responding accounts as necessary. Product destruction will be handled at Stryker Instruments, Kalamazoo. Labeling will be defaced and the Aggressive Blades will be disposed of in the trash compactor. For questions regarding this recall please contact Stryker Instruments: Monday-Friday 8am-5pm (EST) 269-389-2921

Device

Device Recall Hummer IV Microdebrider System
  • Modèle / numéro de série
    P/N 5290-628-000, Lot #13280CG2
  • Classification du dispositif
    Ear, Nose, and Throat Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution including the states of NV, CA, WA, TN, OR, SD, ID, IN and CO., and Internationally to Malaysia
  • Description du dispositif
    2.5MM Aggressive Blade || Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub. || ENT Precision Cutter, Aggressive, ESSxlHUMMER 4, Rx Only || It is used for ENT procedures and functions by means of rotation when adapted to a handpiece and console. Through the rotation, the necessary tissue is resected as required by the user. The blade housing has an etching line guide that starts with a straight line and along with a scale from 1cm to 7cm in 1cm increments that serves the doctor as a guide by indicating how far the device is being introduced into the surgical area.
  • 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