Events

Rappel de Device Recall Farabeuf Clamp for 3.5mm Screws PRO

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 GmbH.

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
    80198
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2244-2018
  • Date de mise en oeuvre de l'événement
    2018-05-04
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164838
  • 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
    Clamp - Product Code HXD
  • Cause
    Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm.
  • Action
    On May 8, 2018, URGENT PRODUCT RECALL and BUSINESS REPLY notices were issued to U.S.A customers via UPS. Customers are encouraged to take the following actions: 1. Inform individuals within your organization who need to be aware of this device recall. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. Response is required by submitted the completed response form via email to: StrykerOrtho6487@stericycle.com, even though you may not have any physical inventory on site anymore. 3. Quarantine and discontinue use of the recalled devices. 4. Maintain awareness of this notice internally until all required actions have been completed within your facility 5. Inform Stryker if any of the subject devices have been distributed to other organizations. a) Please provide contact details so that Stryker can inform the recipients appropriately. b) If you are a Distributor, note that you are responsible for notifying your affected customers. Customers with questions may call 201-831-5000.

Device

Device Recall Farabeuf Clamp for 3.5mm Screws PRO
  • Modèle / numéro de série
    Lot # 04857V
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    AR, CA, ID, IL, MD, MI, NJ, NY, OK, SD & TX
  • Description du dispositif
    Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463
  • Manufacturer
    Stryker GmbH

Manufacturer

Stryker GmbH
  • Adresse du fabricant
    Stryker GmbH, Bohnackerweg 1, Selzach Switzerland
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA