Events

Rappel de Device Recall Stryker

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 Endoscopy.

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
    62346
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1961-2012
  • Date de mise en oeuvre de l'événement
    2012-06-19
  • Date de publication de l'événement
    2012-07-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-10-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110301
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Cause
    The gravity steam, ethylene oxide (eo) and sterrad 100s sterilization methods are being removed from the "instructions for use"; due to the firm's evaluation that identified original validation was not done at worst case conditions.
  • Action
    Stryker Endoscopy sent a Urgent Device Correction letter dated June 19, 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: 1. Discard any old Instructions for Use for your Arthroscope and Hardware Set Tray. 2. Download the new IFU from the URL link: http://stryker.com/arthrotray . Complete and sign the enclosed acknowledgement of receipt form and fax to (408) 754-8378 or scan in and email to trays@stryker.com.* It is important to send the self addressed confirmation form back to Stryker. Stryker is committed to delivering the highest quality products to its customers. We sincerely apologize for any inconvenience this action may cause. If you have any questions regarding this letter please contact us at 1-800-624-4422 or via email at trays@stryker.com. .

Device

Device Recall Stryker
  • Modèle / numéro de série
    All serial/lot numbers
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide)
  • Description du dispositif
    Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distributed by Stryker Endoscopy, San Jose, CA || The Arthroscope and Hardware Set Tray is used to hold and protect surgical devices during the sterilization process. Specifically this tray is used for arthroscopes and arthroscopic hardware devices. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held.
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • Adresse du fabricant
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA