Events

Rappel de Device Recall Stryker 6MM XX COARSE Round DIAMOND BUR, Super Long

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 Instruments 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
    57505
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1241-2011
  • Date de mise en oeuvre de l'événement
    2010-11-30
  • Date de publication de l'événement
    2011-02-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-04-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96412
  • 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
    drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
  • Cause
    Product was packaged with an incorrect packaging material and therefore has a potential to be non-sterile which, if contaminated, could lead to a patient infection.
  • Action
    The firm, Stryker, sent a "MEDICAL DEVICE RECALL NOTIFICATION" letter dated December 2, 2010 to all customers. The letter described the product, problem and the action to be taken by the customers. The customer were asked to complete and fax in the business reply form indicating they have received the notification and to indicate whether or not they have affected product on hand, and send back any affected product to Regulatory Affairs at Stryker Instruments. Stryker will then send a replacement product to the customer. Upon receipt of the completed business reply form, the customer will be contacted to arrange return of any affected product they have in their inventory. Once the affected product is received, a replacement 5190 TPS Series Bur will be sent to the customer. For questions regarding this recall, please contact Stryker Instruments at 1-800-800-4236 ext. 3584 or kathleen.kelly.smith@stryker.com.

Device

Device Recall Stryker 6MM XX COARSE Round DIAMOND BUR, Super Long
  • Modèle / numéro de série
    Part Number 5190013160, Lot 9021017
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including states of: CA, FL, LA, MI, MT, NE, NH, OH, PA, SD, TN, TX, VT, and WA; and countries including: Sweden and Australia.
  • Description du dispositif
    Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. || These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries.
  • Manufacturer
    Stryker Instruments Division of Stryker Corporation

Manufacturer

Stryker Instruments Division of Stryker Corporation
  • Adresse du fabricant
    Stryker Instruments Division of Stryker Corporation, 4100 East Milham Ave., Kalamazoo MI 49001
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA