Events

Rappel de Device Recall CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, and Specialty Head Center Accolade Broach H

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
    57292
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0815-2011
  • Date de mise en oeuvre de l'événement
    2010-11-01
  • Date de publication de l'événement
    2010-12-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-03-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95764
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Cause
    The cuttingedge advantage rasp handle, straight rasp handle, and specialty head center accolade broach handle may fracture in two pieces along the width of the body under the striking plate. this may extend surgical time under anesthesia, cause trauma to the surgeon or patient, or contaminate the surgical site.
  • Action
    Stryker issued a Product Correction Bulletin dated November 2010 to their consignees, alerting surgeons of the need to inspect the instruments before and after each surgical use, and, if a defect is detected, to contact Stryker for return of the product. Stryker can be contacted at 201 831-5288 concerning this issue. In response to their revised strategy, Stryker issued notification letters and product recall acknowledgement forms to their branches and agencies on 2/17/2011 for 2/18/2011 delivery via Fed Ex and to their hospital risk managers on 2/18/2011 for 2/21/2011 delivery via Fed ex.

Device

Device Recall CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, and Specialty Head Center...
  • Modèle / numéro de série
    CuttingEdge Advantage Rasp Handle - Catalog number 1100-1000; All lot codes  Straight Rasp Handle - Catalog number 1440-1400; All lot codes  Specialty Head Center Accolade Broach Handle - Catalog number I-H088HF00, I-H1389HF00 ; All lot codes
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: Throughout the US, the countries of Canada and Japan, and the regions of Asia Pacific, Europe, Middle East, Africa, and Latin America.
  • Description du dispositif
    CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, & Specialty Head Center Accolade Broach Handle; Stryker Howmedica Osteonics, Non-sterile Instruments; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430;
  • 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