Events

Rappel de Device Recall Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock

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
    74619
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2390-2016
  • Date de mise en oeuvre de l'événement
    2016-06-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-08-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148055
  • 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, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
  • Cause
    It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the specialty triathlon tibial alignment handle with secondary lock assembly during surgery. upon further investigation, it was discovered that the weld, which was intended to hold the secondary locking mechanism together, did not meet the weld size specified on the engineering drawing.
  • Action
    Stryker sent an Urgent Product Recall letter dated June 24, 2016, with a Business Reply Form attached to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to inform users of the Urgent Product Recall letter and forward the notice to all those individuals who need to be aware within their organization. Customers were instructed to return all affected product at their location to: Stryker C/O Stericycle 2670 Executive Dr., Suite A Indianapolis, IN 46241 Customers were also instructed to complete and sign the enclosed Business Reply Form and fax it to 888-912-7352 or email to Stericycle at strykerortho4582@stericycle.com. Customers with questions were advised to call (201) 831-6693. For questions regarding this recall call 201-831-5000.

Device

Device Recall Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock
  • Modèle / numéro de série
    Catalog No: I-K3254TA00 Lot Nos: F6E13243, F6L13864, F6M14078, F6S14667, F6S14831, F6W15444, F6W15406, F7C15943, F7H16099 and F7L16994
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution to FL, IN, LA, NC, PA, TN and UT
  • Description du dispositif
    Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, || Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Adresse du fabricant
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA