Events

Rappel de Device Recall Howmedica Osteonics Corp.

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 Howmedica Osteonics Corp..

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
    64942
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1210-2013
  • Date de mise en oeuvre de l'événement
    2013-03-28
  • Date de publication de l'événement
    2013-05-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-11-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117479
  • 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
    Bit, Drill - Product Code HTW
  • Cause
    Stryker orthopaedics has received a report indicating that the scale of the axsos calibrated drill bit 4.3,,x263mm, flat , manufactured by stryker osteosynthesis, is incorrect. the incorrect scale could result in the surgeon selecting a screw that is 10mm longer than intended.
  • Action
    Stryker Orthopaedics sent a Urgent Medical Device Removal letter dated March 28, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Please inform users of this Medical Device Removal and pass this notice to all those individuals who need to be aware within your organization. 2. Return all affected products available at your location to Stryker Osteosynthesis or Contact Stryker Customer Service. 3. Complete and sign the enclosed Business Reply Form and fax a copy to: 1-865-252-3635 . 4. Keep a copy of the completed and executed Business Reply Form for your records. Report any adverse events or product quality problems to Stryker Orthopaedics: 1-866-0R-ASSIST. (1-866-672-7747). As we strive for products that meet your expectations for quality and reliability, please do not hesitate to contact us, in case you have any further questions at (201) 831-5970..

Device

Device Recall Howmedica Osteonics Corp.
  • Modèle / numéro de série
    Catalog number 703615
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including the states of AL, AZ, IL, KY, LA, NJ, NC, FL, CA, NM, MO, TN, VA, CO, MA, TX, IN and MT.
  • Description du dispositif
    Stryker Howmedica Osteonics Corp. AxSOS System Instrument. || The AxSOS Locking Plate System is designed to treat periarticular or intraarticular fractures of the Distal Femur, Proximal Humerus, Proximal Tibia, and the Distal Tibia. Per the operative technique, " A 4.3 mm Drill (REF 702743) is then used to drill the core hole for the locking screw. Using a fluoroscopy, check the correct depth of the drill, and measure the length of the screw. The Drill Sleeve should now be removed, and the correct length 5.0 mm Locking Screw is inserted using the Screwdriver T20 and Screw Holding Sleeve."
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Adresse du fabricant
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA