Events

Rappel de Device Recall 6376 M1 Cot Fastener

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 Medical Division 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
    79817
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1598-2018
  • Date de mise en oeuvre de l'événement
    2018-03-09
  • 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=163571
  • 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
    Stretcher, wheeled - Product Code FPO
  • Cause
    The operations manual and maintenance manual are missing various warnings and contain incorrect information.
  • Action
    On March 9, 2018, the recalling firm notified affected distributors of the issue via their electronic product field action management system, who in turn notified their customers through written communication. Customers were informed of the issue and instructed to do the following: 1. Locate the operations manual shipped with each unit listed on the attached business reply form and replace it with the corrected manual included with the letter. Dispose of the incorrect manual. 2. Return the enclosed business reply form to confirm receipt of this notification to productfieldaction@stryker.com 3. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise the firm of their new location in the space provided on the business reply form. 4. If you have disposed of any of these units, advise the firm of their obsolescence by providing the firm with their serial number in the space provided on the business reply form.

Device

Device Recall 6376 M1 Cot Fastener
  • Modèle / numéro de série
    Serial No. 170740300  170740301  170740302  170740303  170740304  170740305  170740306  170740307  170740308  170740309  170740310  170740311  170740312  170740313  170740314  170740315  170740316  170740317  170740318  170740319  170740320  170740321  170740322  170740323  170740324  170740325  170740326  170740327  170740328  170740329  170740330  170740331  170740332  170740333  170740334  170740335  170740336  170740337  170740338  170740339  170740340  170740341  170740342  170740343  170740344  170740345  170740346  170740347  170740348  170740349  170740350  170740351  170740352  170740353  170740354  170740355  170740356  170740357  170740358
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product distributed to the Netherlands
  • Description du dispositif
    6376 M-1 Cot Fastener, catalog no. 6376000000
  • Manufacturer
    Stryker Medical Division of Stryker Corporation

Manufacturer

Stryker Medical Division of Stryker Corporation
  • Adresse du fabricant
    Stryker Medical Division of Stryker Corporation, 3800 E Centre Ave, Portage MI 49002-5826
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA