BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2261-2015 · Initiated July 16, 2015

    Recall

    Recall Number
    Z-2261-2015
    Event Number
    71715
    Firm
    Otto Bock Healthcare GmbH Max-Nader-Str. # 15 Duderstadt Germany
    FEI Number
    3003117657
    Product Code
    ISY
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    July 16, 2015
    Posted
    July 24, 2015
    Terminated
    June 21, 2017

    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.

    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: [email protected] "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: [email protected].

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: AU, BE, CN, CZ, IT, NL, and SK.

    Quantity

    518 (439 US; 79 OUS)