Events

Rappel de Device Recall Stryker Howmedica Osteonics Accolade Offset Rasp Handle

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
    62130
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1816-2012
  • Date de mise en oeuvre de l'événement
    2011-12-29
  • Date de publication de l'événement
    2012-06-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-06-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109890
  • 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
    Rasp, surgical, general & plastic surgery - Product Code GAC
  • Cause
    Stryker orthopaedics has become aware of the potential for the above noted accolade rasp handle assembly to fracture upon use.
  • Action
    Stryker Orthopaedics sent an email notification to all consignees on December 29, 2011, which was followed by an Urgent Product Recall letter dated January 4, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete the attached Product Recall Acknowledgement Form and fax back to 201-831-8089 within 5 days. Customers were also asked to contact the hospitals in their territory that have the affected product to arrange return of the product. Customers were instructed to return the affected product to the attention of Regulatory Compliance, Stryker Orthopedics, 325 Corporate Drive, Mahwah, New Jersey 07430 with the fluorescent orange PRODUCT REMEDIATION sticker attached indicating the Product Remediation # RA 2011-161. Mark the outer box with the words "Product Recall." For questions customers were instructed to call 201-972-2100. For questions regarding this recall call 201-831-5970.

Device

Device Recall Stryker Howmedica Osteonics Accolade Offset Rasp Handle
  • Modèle / numéro de série
    510K exempt Catalog Number 1020-1400 Lot Code P5E93
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Stryker Howmedica Osteonics Accolade Offset Rasp Handle || Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France || Single offset rasp handle designed to mate to the Accolade femoral broaches to prepare the femoral canal in a total hip anthroplasty using the Accolade Hip System. The offset rasp handle incorporates an offset angle designed to minimize interference with surrounding soft tissue.
  • 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