Events

Recall of Device Recall Ottobock Pheon 3R62 Knee Joint

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Otto Bock Healthcare GmbH.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71715
  • Event Risk Class
    Class 2
  • Event Number
    Z-2261-2015
  • Event Initiated Date
    2015-07-16
  • Event Date Posted
    2015-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138816
  • Notes / Alerts
    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.
  • Extra notes in the data
    Joint, knee, external limb component - Product Code ISY
  • Reason
    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
  • Model / Serial
    The removal affects all devices manufactured and distributed since February 2014.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: AU, BE, CN, CZ, IT, NL, and SK.
  • Product Description
    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
  • Manufacturer Address
    Otto Bock Healthcare GmbH, Max-Nader-Str. #15, Duderstadt Germany
  • Manufacturer Parent Company (2017)
    Otto Bock Holding Gmbh & Co. Kg
  • Source
    USFDA