Events

Rappel de Device Recall External Compression Device

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
    56800
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0330-2011
  • Date de mise en oeuvre de l'événement
    2010-08-30
  • Date de publication de l'événement
    2010-11-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94535
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Cause
    Variations in the outer diameter of the shaft of the external compression device and the inner diameter of the nail holding screw may make assembly of these 2 instruments not possible.
  • Action
    Stryker sent Recall notification letters by Federal Express on September 9, 2010 to all Stryker branches/agencies and Risk Managers, Chief of Orthopaedics of affected hospitals and Surgeons on September 10, 2010, that used the product. The letter identified the product, the problem, and the action that customers should take. Customers were instructed to: Examine their inventory and hospital locations to identify the affected product and return it to their branch or agency warehouse for reconciliation. Reconcile all product on the attached Product Recall Acknowledgment Form and fax a copy to (201) 831-6069 within 5 days of receipt of notice. A Stryker representative would contact the customer with details for return of the product. For any questions regarding this recall call (201) 972-2100.

Device

Device Recall External Compression Device
  • Modèle / numéro de série
    Catalog Number: 1806-1601; Lot code: K228113
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including AZ, CA, CO, FL, GA, IL, KY, MD, OH, OK, and TX
  • Description du dispositif
    External Compression Device; 1 unit per package || Stryker Trauma GmbH; || Distributed by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 || Active Apposition/compression is achieved by threading the External Compression Device into the Nail holding Screw. While being threaded into the Nail Holding Screw the tip of the External Compression Device will contact the (shaft screw(cross screw) and will push the screw in distal direction. As the cross screw is screwed into the bone of the patient, the bone fragment will be moved too is distal direction. Finally both sides of the bone fracture will be pressed together - compression is now applied to the fracture side.
  • 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