Events

Rappel de Device Recall Synthes

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 Synthes, Inc..

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
    67499
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1456-2014
  • Date de mise en oeuvre de l'événement
    2014-01-30
  • Date de publication de l'événement
    2014-04-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125578
  • 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
    Screwdriver, skullplate - Product Code GXL
  • Cause
    The cmf battery powered driver graphic case contains outlines of the battery powered driver, taps, screwdriver blades, and a screw holding sleeve. however, the device is not intended to be used in conjunction with a tap for tapping holes in a patient's skull, upper and/or lower jaw. therefore some outlines in the graphic case suggest a potential use of this device that is considered off-label.
  • Action
    Synthes sent an Urgent Notice: Field Safety Notification letter dated January 30, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please take the following actions; Please see the Battery Powered Driver Users Manual for on-label procedures. You can access an electronic version of the Battery Powered Driver Users Manual by accessing the following : linlc http://www.synthes.com/pages/default.aspx. Click on North America Tab at the top of the screen, and then type Battery Powered Driver Users Manual in the search bar to download the Users Manual Forward this Field Safety Notification to anyone in your facility that needs to be informed. If the graphic case has been forwarded to another facility, contact that facility. " Maintain a copy of this notice. If you have any questions, please call 610-719-5450 or contact your Synthes Sales Consultant. Thank you for your attention to this issue.

Device

Device Recall Synthes
  • Modèle / numéro de série
    Part no. 305.840, with lot nos.: 5680577, 5701123, 5713215, 5763130, 5783316, 5787131, 5828296, 6124867, 6136125, 6150803, 6167974,  6167975, 6218358, 6222322, 6258395, 6365430, 6365431, 6390225,  6425013, 6456634, 6487035, 6556704, 6624880, 6650136, 6668870,  6743859, 6844968, 6926708, 6983799, 7008819, 7038706, 7221395,  7138319.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion.
  • Manufacturer
    Synthes, Inc.

Manufacturer

Synthes, Inc.
  • Adresse du fabricant
    Synthes, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA