BEUDAMED
    FDA Recall Terminated

    SPS Blue Line Tube Clamp Adapters, Product No. BL120M

    Recall: Z-0445-2007 · Initiated October 3, 2006

    Recall

    Recall Number
    Z-0445-2007
    Event Number
    36626
    Firm
    Southern Prosthetic Supply Co.
    FEI Number
    1043591
    Product Code
    ISH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 3, 2006
    Posted
    January 10, 2007
    Terminated
    March 7, 2008
    Address
    6025 Shiloh Rd, Ste A, Alpharetta, GA, 30005-1706

    Description

    SPS Blue Line Tube Clamp Adapters, Product No. BL120M

    Reason

    Device Fracturing: recent design and process changes leave the device susceptible to fracturing, which could cause the prosthesis to fail

    Action

    On October 6, 2006, SPS faxed a recall notification to the 187 customers who had purchased one or more BL120M Tube Clamp Adapters from SPS between August 29 and September 20, 2006. On October 9, SPS contacted those customers that had purchased five or more Adapters via telephone to confirm they had received the faxed recall notification. On October 10, SPS mailed another copy of the recall notification, via certified mail, return receipt requested to all of its customers that had purchased one or more BL120M Tube Clamp Adapters. The customers were told to send the BL120M Adapter back to SPS following replacement.

    Distribution

    Nationwide

    Quantity

    943 units