BEUDAMED
    FDA Recall Terminated

    Spectrum Designs Medical-Nasal Dorsal Columella Implant, Catalog Number: S400-314S and Lot #31053; Serial Numbers: BAG612 ,BAG6I3, BAG6I4, BAG652, BAG654 and BAG655

    Recall: Z-1264-2007 · Initiated July 24, 2007

    Recall

    Recall Number
    Z-1264-2007
    Event Number
    44735
    Firm
    Spectrum Designs Inc
    FEI Number
    1000125318
    Product Code
    LZK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 24, 2007
    Terminated
    July 29, 2011
    Address
    6387 Rose Ln, Ste B, Carpinteria, CA, 93013-2937

    Description

    Spectrum Designs Medical-Nasal Dorsal Columella Implant, Catalog Number: S400-314S and Lot #31053; Serial Numbers: BAG612 ,BAG6I3, BAG6I4, BAG652, BAG654 and BAG655

    Reason

    Mispackaging/Mislabeling: a portion of packaged Nasal LOT 31053 contained chin implants instead of the nasal implant.

    Action

    The firm initiated the recall on 07/24/2007 by contacting the customer (distributor) who filed the original complaint of mislabeling by email. The firm followed-up by sending recall letters (dated July 24, 2007) via FedEx or certified mail with signature confirmation to the one other direct account who received the recalled product on 08/03/2007. Customers were instructed to check their inventory for mislabeled products and call Spectrum at (800)239-6399 to report the number of this product being returned. They were given an address for product return. The firm indicated they will examine returned products, and scrap after examination.

    Distribution

    Nationwide: California and China

    Quantity

    130