Events

Rappel de Triathlon Navigation Tibial Alignment Handle

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
    61343
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1619-2012
  • Date de mise en oeuvre de l'événement
    2011-10-10
  • Date de publication de l'événement
    2012-05-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-09-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108197
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Cause
    Stryker received a product experience report (per) that a swivel block was improperly oriented on a triathlon tibial alignment handle, catalog no. 6541-2-807.
  • Action
    Stryker sent an Urgent Product Field Action letter dated October 10, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their Stryker Sales Representative to arrange for return of the affected product . Customers were asked to fax back the attached Poroduct Field Action Acknowledgement Form as soon as possible to 201-831-6069. For any questions customers were instructed to call 201-972-2100. For questions regarding this recall call 201-831-3523.

Device

Triathlon Navigation Tibial Alignment Handle
  • Modèle / numéro de série
    Catalog No.: 6541-2-807 N1A0l, N1K07 N1K14 N1N64 N1W04 N2A11 N2H10 N2L16 N2N04 N2V25 N2V26 N3E08 N3H12 N3H29 N3K02 N3K56 N3L13 N3S33 N3S39 N3T78 N3V21 N3W18 N3W29 N3W47 NYC02 NYC10 NYL09 NZC10 NZH09 NZL08 NZM01 NZS08 NZV09 customer Parts associated with cat. no. 6540-2-807 I-K2072AH00 - Triathlon Tibial Align. Handle with Secondary Lock I-K2336AH00 - Tibial Alignment Handle with Lock I-K2021TA00 - Triathlon Alignment Handle with Navigation Post I-K2059KT00 - Triathlon Tibia Alignment Handle I-K3254TA00 - Triathlon Tibial Alignment Handle with Lock I-K3251AH00 - Triathlon Tibial Alignment Handle for Sizes 1-3 I-K3113TH00 - Triathlon Tibial Alignment Handles (Augment) I-K2980 - Triathlon Tibia Alignment Handle I-K2954AH00 - Triathlon Tibia Alignment Handle I-K2916TA00 - Triathlon Tibial Alignment Handle I-K2797AH00 - Tibial Alignment Handle with no swivel Catalog No. 6541-2-8089 N1K14 N1N63 N1W08 N3K50 N3M43 N3T61 N3V56 N4E36
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Asia Pacific, Canada, Europe, Middle East and Africa (EMEA), and Japan
  • Description du dispositif
    Tibial Alignment Handle || Triathlon Instruments || CAT #: 6541-2-807 || Nav Tibial Alignment Handle Triathlon Instruments || CAT #; 6541-2-808 || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430 || The tibial alignment handles Cat# 6451-2-807 and 6541-2-808 are part of the Triathlon Knee Instruments set. The alignment handle is used after the tibial resection portion of a total knee arthroplasty procedure. The alignment handle helps holding and orienting the tibial template and trial, which are used to estimate the size and assess the orientation of the final implant. The implant will provide the new bearing surface of the knee, replacing the damaged joint.
  • 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