Events

Rappel de 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
    30379
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0556-05
  • Date de mise en oeuvre de l'événement
    2004-10-27
  • Date de publication de l'événement
    2005-02-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2005-05-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35769
  • 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, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code NPJ
  • Cause
    The fatigue testing of the triathlon ps femoral component does not consistently meet the requirements of the finite element analysis predicted load as delineated in the 510(k) submittal.
  • Action
    Notification letters and Product Accountability Froms have been sent via Fedex on 10/27/2004 with return receipt.

Device

Stryker
  • Modèle / numéro de série
    Catalog Number--Lot Code: 5511-F-301--ER0215; 5511-F-301--PR04139; 5511-F-301--PR04664; 5511-F-301--PR04862; 5511-F-301--PR04891; 5511-F-301--PR04955; 5511-F-301--PR41122; 5511-F-301--PR4352; 5511-F-301--PR4424; 5511-F-301--PR4425; 5511-F-301--PR4427; 5511-F-301--PR4519; 5511-F-301--PR4734; 5511-F-301--PR4736;  5511-F-302--ER0184; 5511-F-302--PR04795; 5511-F-302--PR04808; 5511-F-302--PR04809; 5511-F-302--PR04810; 5511-F-302--PR04840; 5511-F-302--PR04887; 5511-F-302--PR04902; 5511-F-302--PR4113; 5511-F-302--PR41142; 5511-F-302--PR41143; 5511-F-302--PR4256; 5511-F-302--PR42561; 5511-F-302--PR4429; 5511-F-302--PR4430; 5511-F-302--PR4432; 5511-F-302--PR4520; 5511-F-302--PR4727; 5511-F-302--PR4738; 5511-F-302--PR4739; 5511-F-302--PR4774; 5511-F-302--PRO4626; 5511-F-302--PRO4627; 5511-F-302--PRO4629;  5511-F-401--PR04811; 5511-F-401--PR04848; 5511-F-401--PR04849; 5511-F-401--PR04865; 5511-F-401--PR04866; 5511-F-401--PR04867; 5511-F-401--PR04881; 5511-F-401--PR04882; 5511-F-401--PR4107; 5511-F-401--PR41073; 5511-F-401--PR4115; 5511-F-401--PR4435; 5511-F-401--PR4437; 5511-F-401--PR4718; 5511-F-401--PR4740; 5511-F-401--PR4775; 5511-F-401--PR4779;  5511-F-402--ER0219; 5511-F-402--PR04805; 5511-F-402--PR04805; 5511-F-402--PR04806; 5511-F-402--PR04850; 5511-F-402--PR04851; 5511-F-402--PR04880; 5511-F-402--PR04905; 5511-F-402--PR04906; 5511-F-402--PR4116; 5511-F-402--PR4258; 5511-F-402--PR4440; 5511-F-402--PR4442; 5511-F-402--PR4443; 5511-F-402--PR4716; 5511-F-402--PR4728; 5511-F-402--PR4777;  5511-F-501--ER0217; 5511-F-501--ER0250; 5511-F-501--PR4117; 5511-F-501--PR4118; 5511-F-501--PR4254; 5511-F-501--PR42541; 5511-F-501--PR42593; 5511-F-501--PR4418; 5511-F-501--PR4444; 5511-F-501--PR4445; 5511-F-501--PR4446; 5511-F-501--PR4448; 5511-F-501--PR4449; 5511-F-501--PR4450; 5511-F-501--PR4452; 5511-F-501--PR4524; 5511-F-501--PR4767;  5511-F-502--ER0218; 5511-F-502--PR04884; 5511-F-502--PR04885; 5511-F-502--PR05008; 5511-F-502--PR41191; 5511-F-502--PR41194; 5511-F-502--PR4379; 5511-F-502--PR4456; 5511-F-502--PR4457; 5511-F-502--PR4458; 5511-F-502--PR4459; 5511-F-502--PR4460; 5511-F-502--PR4461; 5511-F-502--PR4525; 5511-F-502--PR4526; 5511-F-502--PR4527; 5511-F-502--PR4768; 5511-F-502--PR4778;  5511-F-601--ER0185; 5511-F-601--ER0280; 5511-F-601--PR04886; 5511-F-601--PR04904; 5511-F-601--PR05021; 5511-F-601--PR05052; 5511-F-601--PR05229; 5511-F-601--PR41421; 5511-F-601--PR41422; 5511-F-601--PR41423; 5511-F-601--PR4464; 5511-F-601--PR4528; 5511-F-601--PR4529; 5511-F-601--PR4752; 5511-F-601--PR4753; 5511-F-601--PR4798; 5511-F-601--PR5026; 5511-F-601--PR5032; 5511-F-601--PR5037; 5511-F-601--PR5046; 5511-F-601--PR5108; 5511-F-601--PR5110;  5511-F-602--ER0186; 5511-F-602--ER0253; 5511-F-602--ER0254; 5511-F-602--ER0265; 5511-F-602--J66915; 5511-F-602--PR04662; 5511-F-602--PR04828; 5511-F-602--PR04863; 5511-F-602--PRO4864; 5511-F-602--PR4099; 5511-F-602--PR42731; 5511-F-602--PR4470; 5511-F-602--PR4471; 5511-F-602--PR4472; 5511-F-602--PR4754; 5511-F-602--PR4757; 5511-F-602--PR4772; 5511-F-602--PR4776; 5511-F-602--PR4781; 5511-F-602--PR4901; 5511-F-602--PR5111; 5511-F-602--PR5112.  Several units of the same lot number are reported in the quantity distributed.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    The product is distributed to its branches/agencies and to hospitals nationwide.
  • Description du dispositif
    The Triathlon Posteriorly Stabilized Femoral Component.
  • 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