BEUDAMED
    FDA Recall Terminated

    Medipro OP4 Prosthetic Knee Joint (external for prosthesis, not implant).

    Recall: Z-0759-2007 · Initiated August 11, 2006

    Recall

    Recall Number
    Z-0759-2007
    Event Number
    37604
    Firm
    Medi Manufacturing Inc
    FEI Number
    3000719631
    Product Code
    ISY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 11, 2006
    Posted
    April 24, 2007
    Terminated
    April 12, 2011
    Address
    6481 Franz Warner Pkwy, Whitsett, NC, 27377-3000

    Description

    Medipro OP4 Prosthetic Knee Joint (external for prosthesis, not implant).

    Reason

    Joints contain a component manufactured with an alloy that may not comply with manufacturer's specifications.

    Action

    Each consignee was contacted by phone on 8/11/2006. A follow up letter was sent to consignees on 8/11/2006 providing details on who to contact and how to return the affected devices for replacement. A self addressed, stamped response form was included to be completed and returned to Medi.

    Distribution

    Nationwide.

    Quantity

    8 units