Events

Rappel de Device Recall Stryker

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
    69065
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0065-2015
  • Date de mise en oeuvre de l'événement
    2014-07-24
  • Date de publication de l'événement
    2014-10-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129490
  • 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
    Stryker orthopaedics received a report indicating some of the nail insertion sleeves had a different inner diameter than described on the package label.
  • Action
    Stryker Orthopaedics sent an "Urgent Medical Device Removal" letter dated July 23, 2014 and Business Reply Form to their Branches/Agencies via e-mail on July 23, 2014 and their Hospital Risk Management was sent Notification Letters and Product Accountability Forms via FedEx (with return receipt) by July 24, 2014. The recall letter informed the customer of the problem. The customer was asked to return all affected products available to Stryker Osteosynthesis, c/o Paul Jahnke, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430, REF: PFA #2014-101 or Contact Stryker's customer service and refer to PFA #2014-101 for returning the product to Stryker. Customers were asked to complete and sign the enclosed Business Reply Form and fax a copy to: 1 (855) 251-3635 or email a copy to Aminah Crawford, Recall Coordinator at aminah.crawford@stryker.com.

Device

Device Recall Stryker
  • Modèle / numéro de série
    Catalog #1806-1406S - Lot #'s K019A3C, K031467, K032811, K032812, K06AAA8, K07F95F and K083672, expiry date 3/31/2019 and Catalog #1806-1407S - Lot #'s K031468, K03E8AD and K074529, expiry date 3/31/2019
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution in the states of CA, FL, IN, MD, NC, NH, NY, OH, PA and WI.
  • Description du dispositif
    Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. || Product Usage: || The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Adresse du fabricant
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA