Events

Rappel de Device Recall TOM(R) Bone Mill

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 Craniomaxillofacial Division.

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
    54663
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1202-2010
  • Date de mise en oeuvre de l'événement
    2010-02-18
  • Date de publication de l'événement
    2010-03-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-11-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88953
  • 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
    Tessier Osseous Microtome [TOM(R)] - Product Code LXH
  • Cause
    The firm has received 328 customer complaints for this device. most of the complaints were involving non-functioning of the ratcheting handle or complete device, or the presence of metal shavings or discoloration.
  • Action
    An "URGENT MEDICAL DEVICE CORRECTION" letter dated February 18, 2010, was sent to the customers. The letter describes the product, problem, scope of affected products, potential patient risks and actions to be taken by the customers. The customers should review the letter with all users of the TOM(r) Bone Mill and follow the instructions on the proper inspection and maintenance of the device enclosed with the letter. The customers should fax the accountability form within 5 days to help Stryker ensure their receipt of the information. If the accountability form is not received, addition communication will be sent. If you have any urgent questions or concerns, please contact us at (269) 323-4258. Please ref: PFA #2009-128. Our normal business hours are Monday-Friday 8am-5pm (GMT+1:00) On 7/8/2010 the firm sent an Urgent Medical Device Recall letter to its customers. The letter stated thatt upon consultation with regulatory agencies outside of the United States, the firm had intiated a devicd removal. The letter instructed the customers to return any devices that they had to the recalling firm.

Device

Device Recall TOM(R) Bone Mill
  • Modèle / numéro de série
    all lots.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and Belarus, Bulgaria, Denmark, Finland, Hungary, Jordan, Norway, Russia, Saudi Arabia and the UAE.
  • Description du dispositif
    Tessier Osseous Microtome TOM(R) Bone Mill, 01-15402, Stryker Portage, MI. || The TOM bone mill is designed to grind any type of cortical or cancellous bone.
  • Manufacturer
    Stryker Craniomaxillofacial Division

Manufacturer

Stryker Craniomaxillofacial Division
  • Adresse du fabricant
    Stryker Craniomaxillofacial Division, 750 Trade Centre Way Ste 200, Portage MI 49002-0482
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA