Events

Rappel de Device Recall Ottobock Pheon 3R62 Knee Joint

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 Otto Bock Healthcare GmbH.

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
    71715
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2261-2015
  • Date de mise en oeuvre de l'événement
    2015-07-16
  • Date de publication de l'événement
    2015-07-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138816
  • 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
    Joint, knee, external limb component - Product Code ISY
  • Cause
    Otto bock healthcare gmbh is voluntarily recalling all 3r62 pheon polycentric prosthetic knee joints distributed since february 2014 because the locking function may fail under certain conditions which may result in a fall.
  • Action
    The firm, Ottobock, sent an "URGENT MEDICAL DEVICE RECALL 3R62 Pheon" letter dated 16 July 2015 to its customers. The letter described the product, problem, and actions to be taken. The customers instructed to read this notice in its entirety; examine your stock for 3R62 Pheon devices; quarantine 3R62 Pheon devices and prevent further distribution; contact Ottobock customer service at (800) 328-4058-option 1 or (512) 806-2000 -Option 1, to obtain a return authorization for those devices, and complete and return the MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form via email to: USRecalls@ottobock.com "Pheon Recall"; fax (801) 974-6718-"Pheon Recall" or mail to: Otto Bock HealthCare LP, ATTN: PHEON RECALL, 3820 W. Great Lakes Drive, Salt Lake City, UT 84120-B7 is re-designing the locking function to prevent this failure from occurring. The re-designed devices will be available for replacement sometime within the next few months. If you have any questions contact Director, Regulatory & Quality Compliance at (801) 974-6618 or email: Lex.Pearce@ottobock.com.

Device

Device Recall Ottobock Pheon 3R62 Knee Joint
  • Modèle / numéro de série
    The removal affects all devices manufactured and distributed since February 2014.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: AU, BE, CN, CZ, IT, NL, and SK.
  • Description du dispositif
    Ottobock Pheon 3R62 Knee Joint || The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attachment to other components based on the patient need and physiology.
  • Manufacturer
    Otto Bock Healthcare GmbH

Manufacturer

Otto Bock Healthcare GmbH
  • Adresse du fabricant
    Otto Bock Healthcare GmbH, Max-Nader-Str. #15, Duderstadt Germany
  • Société-mère du fabricant (2017)
    Otto Bock Holding Gmbh & Co. Kg
  • Source
    USFDA