Events

Rappel de Device Recall Howmedica 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
    36973
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0473-2007
  • Date de mise en oeuvre de l'événement
    2006-11-28
  • Date de publication de l'événement
    2007-01-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-05-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49724
  • 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
    Hip Stem - Product Code KWL
  • Cause
    Lack of assurance of sterility (package integrity): anomalies in seal width and strength that may affect the integrity of the sterile barrier.
  • Action
    Recall notification letters and product accountability forms were sent on 11/29 via Fed Ex with return receipt.

Device

Device Recall Howmedica HIp Stem
  • Modèle / numéro de série
    Hip Fracture Stem # 2: Catalog Number 6942-0-020; Lot Codes: 7237501, 7237502, 7237503, 7237505, 7600201, 7600202, 7662301, 7662302, 7662303, 7662304, 7692401, 7692402, 7692403, 7692406, 7805601, 7805602, 7805603, 7805604, 7934901, 7934902, 7944903, 7934904, 7999101, 7999102, 7999103, 7999104, 8152001, 8152002, 8152003, 8152004, 8152005, 8152006, 8152101, 8152102, 8152103, 8152104, 8241701, 8241702, 8241703, 8241704, 8241705, 8241706, 8345701, 8345702, 8345703, 8345704, 8478101, 8478102, 8478103, 8478104, 8569601, 8569602, 8632901, 8632902, 8633001, 8633101, 8633201, 8791103, 8791104, 8971301, 8993501, 8994801, 8995001, 8995601, 8995701, 9004401, 9004402, 9243601, 9243602, 9243603, 9400701, 9400702, 9400703, 9400704, 9400705, 9400706, 9475901, 9714101, 9714102, 9714104, 9911701, 9911702, 9911703, 9911705, 9911706, 9967201, 9967202, 9967203, 10353602, 10362901, 10420901, 10421001, 10585002, 10585003, 10585004, 10585005, 10585006, 10673301, 10673302, 10673303, 11064601, 11064602, 11064603, 11089903, 11089904, 11369301, 11369302, 11369303, 11436901, 11436902, 11605301, 11604302, 11791901, 11791902, 11791903, 11920901, 11920902, 11920903, 12084501,12084502, 12084503, 12084505, 12406801, 12406802, 12406803, 12406901, 12947501, 12947502, 12947503, 12947504, 13184201, 13184202, 13184203, 13184204, 13184301, 13412201, 13412202, 13412203, 13782102, 13782104, 13793501, 13973502, 13984701, 13984702, 13984703, 14108402, 14196701, 14196702, 14274601, 14368101, 14368102, 14368103, 15485101, 15485102, 15485103, 15485104, 15485105, 15668701, 15668702, 15953601, 15953602, 15953603, 15953604, 15953605, 15953606, 16059801, 16059802, 16059803, 16165601, 16203701, 16203702, 16499401, 16499402, 16499403, 16499404, 16937901, 16937902, 16937904, 17220101, 17220102, 17220103, 17220104, 17307801, 17307802, 17307804, 17658001, 17658002, 17658003, 17745201, 17745202, 17745203, 17969401, 17969402, 18320601, 18320602, 18448602, 18594101, 18594102, 18594601, 19246901, 19247001, 19247101, 19329001, 19329002, 19532501, 19532504, 19577101, 19577102,19826201, 19826203, 15953604R, 19329001R, 7805601R.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide
  • Description du dispositif
    Howmedica Hip Fracture Stem System || No. 2 Femoral Component || Fenestrated || Sterile REF Catalogue #6942-0-020 || Made in Ireland
  • 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