BEUDAMED
    FDA Recall Terminated

    Spectrum Designs Medical Anatomical I (Silhouette) Malar Facial Implant, Catalog Number 120-224S.

    Recall: Z-1206-2007 · Initiated June 15, 2007

    Recall

    Recall Number
    Z-1206-2007
    Event Number
    38898
    Firm
    Spectrum Designs Inc
    FEI Number
    1000125318
    Product Code
    LZK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 15, 2007
    Posted
    August 29, 2007
    Terminated
    March 7, 2012
    Address
    6387 B Rose Lane, Carpinteria, CA, 93013

    Description

    Spectrum Designs Medical Anatomical I (Silhouette) Malar Facial Implant, Catalog Number 120-224S.

    Reason

    The product is being recalled because it was discovered the at least one unit in the lot contained a mismatched pair (two rights and no left). Since the lot was produced with equal numbers of pairs, it is assumed that one other unit was packaged with two lefts and no right. This was discovered through a physician complaint.

    Action

    The firm initiated the recall on 06/15/2007 by contacting their customers by telephone. The firm followed-up by sending recall letters via FedEx or certified mail with signature confirmation to each direct account who received the recalled product on 06/18/2007.

    Distribution

    Nationwide.

    Quantity

    15 pairs (left/right)