Events

Rappel de Device Recall Flat Proximal Pressurizer.

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
    60892
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1198-2012
  • Date de mise en oeuvre de l'événement
    2012-01-13
  • Date de publication de l'événement
    2012-03-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106727
  • 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
    Dispenser, cement - Product Code KIH
  • Cause
    The firm identified two complaints have been reported indicating that the product inside the package did not match with the label information. the product was labeled as flat proximal pressurizer p/n 0206-556-000 while the product inside the package was femoral pressurizer p/n 0206-566-000.
  • Action
    Stryker Instruments sent an "Urgent Medical Device Recall notification" dated January 13, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to : Immediately check all stock areas or operating room storage and quarantine any affected product found. Mark product as RECALLED PRODUCT. Please indicate on the BRF the quantity of affected Pressurizers you are returning and fill in the form completely. Sign the BRF (even if you do not have any affected product). Note: Your signature on the BRF indicates that you received and understand this notification and are returning all affected product from your facility. Fax the Business Reply Form to Stryker Instruments Regulatory Department, 866-521-2762. Upon receipt of the BRF, Stryker will contact you to coordinate the return of all affected product that you have on hand. Send back all affected product using the pre-paid shipper provided to you by Stryker. Upon receipt of the product, a replacement will be issued to your account

Device

Device Recall Flat Proximal Pressurizer.
  • Modèle / numéro de série
    Part Number: 0206-556-000; Lot: 11271012
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- Nationwide, including the states of AL and OK and the country of Canada.
  • Description du dispositif
    Flat Proximal Pressurizer. || Bone cement pressurizers are intended to help seal the delivery path between the delivery nozzle and bone in order to pressurize the cement during delivery.
  • 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