Events

Rappel de Device Recall JTS External Drive Unit (JTS Grower Drive)

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 Stanmore Implants Worldwide Ltd..

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
    77753
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3104-2017
  • Date de mise en oeuvre de l'événement
    2017-07-04
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157829
  • 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, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
  • Cause
    Three (3) complaints were identified in which the potential for utilization of the jts grower drive in the incorrect orientation in relation to the limb entry point of the device, together with the potential to select incorrect settings for the extension procedure. as a result, the prostheses in such cases failed to extend as intended.
  • Action
    Stanmore Implants sent an Urgent Field Safety Notice dated July 4, 2017, notifying customers of the recall. Additionally, the recalling firm requests that consignees immediately check their inventory for recalled product, quarantine any product on hand, inform SIW of any product on hand, complete the attached response form, and return the response for and affected product to the firm. It is requested that consignees distribute the notice internally to all affected parties and that they contact their local Stanmore representative to request training. If any adverse events are associated with this device, the firm asks that it be reported to them. For further questions, please call (972) 501-1402.

Device

Device Recall JTS External Drive Unit (JTS Grower Drive)
  • Modèle / numéro de série
    Product Code MLE3; Serial No. 907-103, 907-104, 907-119, 907-123, 907-125, 907-126, 907-127, 907-028, 907-237, 907-240, 907-500, 907-501, 907-502, 907-503, 907-504.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution to the states of : CA, FL, GA, KS, MI, NJ, OH, PA, SC, and TX.
  • Description du dispositif
    JTS External Drive Unit || JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
  • Manufacturer
    Stanmore Implants Worldwide Ltd.

Manufacturer

Stanmore Implants Worldwide Ltd.
  • Adresse du fabricant
    Stanmore Implants Worldwide Ltd., Centennial Park, 210 Centennial Avenue; CENTENNIAL PARK, Borehamwood United Kingdom
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA