Events

Rappel de Device Recall Stryker Orthopaedics Hoffman LRF Telescopic Strut

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
    63273
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0266-2013
  • Date de mise en oeuvre de l'événement
    2012-07-03
  • Date de publication de l'événement
    2012-11-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113356
  • 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
    Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
  • Cause
    Three complaints have been filed where the hoffman lrf telescopic struts have broken during load bearing application by patients having a body weight greater than 250 lbs.
  • Action
    Stryker Orthopaedics sent an "URGENT MEDICAL DEVICE FIELD REMOVAL" letter dated July 2, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Business Reply Form was included for customers to complete and return to via fax to 1-865-252-3635. Contact the firm at 1-866-626-7747 for assistance.

Device

Device Recall Stryker Orthopaedics Hoffman LRF Telescopic Strut
  • Modèle / numéro de série
    K113327 Catalog No:  Telescopic Strut Extra Short Hoffman LRF Length: 4933-0-100 :100-125mm (Black) 4933-0-120 Telescopic Strut Short Hoffman LRF Length: 119-161 mm (Yellow) 4933-0-140 Telescopic Strut Medium Hoffman LRF Length 138-201 mm (Blue) 4933-0-180 Telescopic Strut Long Hoffman LRF Length: 177-277 mm (Red);  Lot Code: 4933-0-100 Telescopic Strut Extra Short Hoffman LRF Length 100-125mm (Black) X28937; Z04197; Z09163; Z09597; Z12135;   4933-0-120 Telescopic Strut Short Hoffman LRF Length: 119-161 mm (Yellow) X28961; Z04199; Z09161; Z09769; Z12012;   4933-0-140 Telescopic Strut Medium Hoffman LRF Length 138-201 mm (Blue) X34352; Z04200; Z05068; Z09011; Z09598; Z10872;   4933-0-180 Telescopic Strut Long Hoffman LRF Length: 177-277 mm (Red); X28963 ;Z04429; Z09471; Z11686
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    Hoffman LRF Telescopic Strut Short || Stryker || Stryker Trauma AG || CH-2545 Seizach || Distributed in the USA by || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430. || The use of external devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices are intended only to assist healing and are not intended to replace normal bone structures. External fixation devices are intended to hold fractured bone surfaces in apposition to facilitate normal healing. While proven successful, the devices are manufactured from metal, plastic, and composite materials. No such fracture fixation device, subject to fatigue, can be expected to withstand activity levels in the same way as would a normal health bone. The external fixation system, therefore, will not be as strong, reliable or durable as a normal human bone.
  • 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