Events

Rappel de Device Recall Restoration

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.

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
    28052
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0571-04
  • Date de mise en oeuvre de l'événement
    2003-12-30
  • Date de publication de l'événement
    2004-07-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-02-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31115
  • 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, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented - Product Code LZO
  • Cause
    Restoration t3 revision hip system distal stem has demonstrated fractures.
  • Action
    Product recall letters and accountability forms were sent via FedEx on 12/30/2003 with return receipt.

Device

Device Recall Restoration
  • Modèle / numéro de série
    All Lots
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    The following direct accounts received the device: Branches/Agencies: 46; Hospitals: 526; Government Hospitals: 23; International Distributors: 10; Latin America: 3; Canada: 1; and Asia Pacific: 3.
  • Description du dispositif
    Restoration T3 Revision Hip System, Femoral Hip Prosthesis. Various lengths and Model numbers. || 6260-3-014 T3 MOD REV DIST STM 14MMX225MM; || 6260-3-015 T3 MOD REV DIST STM 15MMX225MM; || 6260-3-016 T3 MOD REV DIST STM 16MMX225MM; || 6260-3-017 T3 MOD REV DIST STM 17MMX225MM; || 6260-3-018 T3 MOD REV DIST STM 18MMX225MM; || 6260-3-019 T3 MOD REV DIST STM 19MMX225MM; || 6260-3-020 T3 MOD REV DIST STM 20MMX225MM; || 6260-3-022 T3 MOD REV DIST STM 22MMX225MM; || 6230-3-024 T3 MOD REV DIST STM 24MMX225MM; || 6260-3-114 T3 MOD REV DIST STM 14MMX265MM; || 6260-3-115 T3 MOD REV DIST STM 15MMX265MM; || 6260-3-116 T3 MOD REV DIST STM 16MMX265MM; || 6260-3-117 T3 MOD REV DIST STM 17MMX265MM; || 6260-3-118 T3 MOD REV DIST STM 18MMX265MM; || 6260-3-119 T3 MOD REV DIST STM 19MMX265MM; || 6260-3-120 T3 MOD REV DIST STM 20MMX265MM; || 6260-3-122 T3 MOD REV DIST STM 22MMX265MM; || 6260-3-124 T3 MOD REV DIST STM 24MMX265MM; || 6260-3-214 KINKED T3 DIST STM 14MMX265MM; || 6260-3-215 KINKED T3 DIST STM 15MMX265MM; || 6260-3-216 KINKED T3 DIST STM 16MMX265MM; || 6260-3-217 KINKED T3 DIST STM 17MMX265MM; || 6260-3-218 KINKED T3 DIST STM 18MMX265MM; || 6260-3-219 KINKED T3 DIST STM 19MMX265MM; || 6260-3-220 KINKED T3 DIST STM 20MMX265MM; || 6260-3-222 KINKED T3 DIST STM 22MMX265MM; || 6260-3-224 KINKED T3 DIST STM 24MMX265MM; || 6260-3-314 KINKED T3 DIST STM 14MMX305MM; || 6260-3-315 KINKED T3 DIST STM 15MMX305MM; || 6260-3-316 KINKED T3 DIST STM 16MMX305MM; || 6260-3-317 KINKED T3 DIST STM 17MMX305MM; || 6260-3-318 KINKED T3 DIST STM 18MMX305MM; || 6260-3-319 KINKED T3 DIST STM 19MMX305MM; || 6260-3-320 KINKED T3 DIST STM 20MMX305MM; || 6260-3-322 KINKED T3 DIST STM 22MMX305MM; || 6260-3-324 KINKED T3 DIST STM 24MMX305MM; || LR3ST RESTORATION REV HIP SYS SURGICAL TECHNIQUE; || 6262-7-000-0 RESTORATION REV HIP SYS TEMPLATE SET FOR STRAIGHT STEMS ONLY; || LTEM71 1-9 RESTORATION REV HIP SYS 265MM BOWED STEM TEMPLATES; || LTEM72 1-9 RESTORATION REV HIP SYS 305MM BOWED STEM TEMPLATES.
  • Manufacturer
    Stryker Howmedica Osteonics

Manufacturer

Stryker Howmedica Osteonics
  • Adresse du fabricant
    Stryker Howmedica Osteonics, 300 Commerce Ct, Mahwah NJ 07430-2104
  • Source
    USFDA