Events

Rappel de Device Recall Stryker Howmedica Osteonics

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
    67055
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0849-2014
  • Date de mise en oeuvre de l'événement
    2013-11-07
  • Date de publication de l'événement
    2014-01-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-03-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124623
  • 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 became aware during laboratory testing that there is a potential that the seal integrity of the outer pouch (sterile barrier) may be compromised for certain lots of the product teflon tube, sterile.
  • Action
    The firm, Stryker, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated December 17, 2013 to its customers via e-mail. Preliminary notification letters and Product Accountability Forms were sent via FedEx on November 15, 2013 with return receipt to the Stryker locations. Notification and Product Accountability Forms were sent 12/18/2013 via Fed Ex with return receipt. Updated letters were sent via Fed Ex on 12/19/2013 with return receipt. The letter described the product, problem and actions to be taken. The customers were instructed to quarantine affected devices in local inventory as well as retrieve any devices located in hospitals; inform users of the Medical Device Removal and pass this to all those individuals who need to be aware within your organization; return all affected products available to your location to: Stryker Osteosynthesis, c/o Colleen O'Meara, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ, 07430, REF: PFA#2013-168 or contact Stryker customer service and refer to PFA #2013-166 for returning the product to us; complete and return the enclosed Business Reply Form and fax a copy to: 1-865-251-3635 or email a copy to Recall Coordinator at aminah.crawford@stryker.com, and keep a copy of the completed and executed Business Reply form for your records. If you have any further questions, contact Manager, Regulatory Compliance at 1-201-972-2100 or email: colleen.omeara@stryker.com.

Device

Device Recall Stryker Howmedica Osteonics
  • Modèle / numéro de série
    Catalog Number 1806-0073S Lot Code K06C3B4, K05ECF3, K05ECF2, K057298, K0432D3
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution in states of: GA, IL, KY, MI, MO, NJ, TN, UT and VA.
  • Description du dispositif
    Teflon Tube, sterile || T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 || 24232 Sconkidrchen, Germany || distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA || 510 K042396 || Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires: T2 Tibial Nailing Systems, T2 Femoral Nailing Systems, T2 Ankle Nailing Systems, and T2 Humerus Nailing Systems
  • 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