Events

Rappel de ABG II Modular Hip Stem

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
    62456
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2089-2012
  • Date de mise en oeuvre de l'événement
    2012-04-30
  • Date de publication de l'événement
    2012-07-26
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110697
  • 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
    Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
  • Cause
    Stryker has updated the instruction for use (ifu) (product correction)for the abgii modular and rejuvenate modular hip systems. this is based on a reported rate of less than one percent for revisions potentially associated with fretting and or corrosion at or about the modular neck junction. on june 29, 2012, stryker has decided to remove the affected product from the field since there may be an.
  • Action
    Stryker sent an "URGENT PRODUCT CORRECTION" letter dated April 23, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included a Product Correction Acknowledgment Form for customers to complete and return via fax to 201-831-6069. Contact the firm at 201-831-5970 for questions regarding this notice. Stryker sent and "Urgent Update Product Recall" Letter dated January 3, 2013 to all affected customers. The new letter includes updated corrective actions for patients. Another letter was sent out on 7/25/2014.

Device

ABG II Modular Hip Stem
  • Modèle / numéro de série
    510 K092406  all lots  (4845-4XXX and NLS/NLV)
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    ABG II Modular Hip Stem || Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 || Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. || The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.
  • 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