Events

Rappel de Device Recall METS

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
    75892
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0824-2017
  • Date de mise en oeuvre de l'événement
    2016-12-07
  • Date de publication de l'événement
    2016-12-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-07-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151732
  • 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
    The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
  • Action
    Stanmore Implants sent an Urgent Field Safety Notice dated November 25, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to immediately check their internal inventory and quarantine all subject devices, circulate the Field Safety Notice internally to all interested/affected parties, maintain awareness of the notice internally until all required actions have been completed within their facility, inform Stanmore Implants if any of the subject devices have been distributed to other organizations, complete the attached customer response form and list of affected batches form, return the completed form and any affected devices to their S/W Representative. Customers with questions were instructed to contact their local sales representative.

Device

Device Recall METS
  • Modèle / numéro de série
    B10586, B11126, B9875, B9946, B10751, B11513, B9874, B10602, B9876
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA
  • Description du dispositif
    DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Integral Shaft & Stem 30x36x44 || The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
  • Manufacturer
    Stanmore Implants Worldwide Ltd.

Manufacturer

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