Events

Rappel de Device Recall Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM

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
    71429
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2102-2015
  • Date de mise en oeuvre de l'événement
    2015-06-02
  • Date de publication de l'événement
    2015-07-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-09-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138120
  • 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
    Instrument, biopsy - Product Code KNW
  • Cause
    Stryker instruments is recalling the stryker selectcore variable throw biopsy device due to the potential for for the stylet to eject from the selectcore device during actuation.
  • Action
    Stryker distributed Customer Notification Letters via Fed Ex overnight to be delivered on 06/10/2015. Customers are asked to Immediately review this Recall Notification. 2. Immediately check all stock areas and/or operating room storage and quarantine any affected product found. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify how many, if any, affected items are currently in your inventory. Please complete and return the BRF even if you do not have any affected product on hand. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in this Notification. 4. 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. 5. Fax (866-521-2762) or email (julie.forsyth@stryker.com) the completed Business Reply Forms; and return the recalled SelectCore devices(s) to Stryker.

Device

Device Recall Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM
  • Modèle / numéro de série
    Stryker Model Number: 0904-410-000; Lot# 61406001
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution in the states of: TX, NJ and MS.
  • Description du dispositif
    Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM || Product Usage: || The Stryker SelectCore Variable Throw Biopsy Device is used in obtaining biopsy samples from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors. For breast biopsy this product is for diagnosis onlynot therapeutic use.. These devices are sterile, single use devices.
  • 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