Events

Rappel de Device Recall LP Rotate Foot System

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 Ossur H / F.

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
    70648
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1288-2015
  • Date de mise en oeuvre de l'événement
    2015-03-04
  • Date de publication de l'événement
    2015-03-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-10-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134240
  • 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
    Component, external, limb, ankle/foot - Product Code ISH
  • Cause
    The threads of the outer tube of the shock module of lp rotate are too short, resulting in insecure assembly. use of the product may cause the patient to fall with continued use, as the shock module can become loose from the foot blade.
  • Action
    The firm's recall letter states the following instructions: Immediately examine inventory and quarantine product subject to the recall. In addition the firm asks if further distributed to identify the customers and notify them of the recall. The firm states that notification may be enhanced by providing a copy of the letter. The firm states that the recall notice needs to be passed along to all those who need to be aware. The firm also states that if customers are wearing a faulty product that they recommend them scheduling a visit to have the product replaced with a new LP Rotate that is currently available. The firm states that they can also arrange pick-up of defected products. For any questions the firm provides a customer service contact: Jamie Dutter, Senior Customer Service Representative.

Device

Device Recall LP Rotate Foot System
  • Modèle / numéro de série
    LP Rotate, sizes 25-27 cat.1-6. Product numbers LRP062, LRF062, LRPU62, LRFU62. All from manufacturing lot number HF141022
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide within the U.S. and internationally to the following foreign countries; Belgium, United Kingdom, Germany, Czech Republic, France, Israel, Poland, Spain, Australia, Japan, Mexico, Bulgaria, Canada, South Korea, Sweden, Finland,
  • Description du dispositif
    LP Rotate Foot System prosthetic device for fitting lower extremity amputations. || -Low profile foot module with adjustable shock absorber and rotation || with progressive stiffening || -Build height: with male pyramid adapter 145 - 153mm (5 11/16 - 6 ) || with female pyramid adapter 153 165mm (6 - 6 1/2) || -Male pyramid adapter || -Female pyramid adapter || -Maintenance free, no lubrication required || -Maximum weight: 147kg (325lbs) || -Available in sizes 22-30
  • Manufacturer
    Ossur H / F

Manufacturer

Ossur H / F
  • Adresse du fabricant
    Ossur H / F, Grjothals 5, Reykjavik Iceland
  • Société-mère du fabricant (2017)
    Össur hf
  • Source
    USFDA