BEUDAMED
    FDA Recall Terminated

    TruFit BGS Plug Size Code Blue, 9mm; quantity 1; Part #600-001-05; product labeled as sterile; manufactured by OsteoBiologics, Inc., San Antonio, TX.

    Recall: Z-0443-2007 · Initiated September 29, 2006

    Recall

    Recall Number
    Z-0443-2007
    Event Number
    36521
    Firm
    Smith & Nephew, Inc. Endoscopy Division
    FEI Number
    3003604053
    Product Code
    MQV
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 29, 2006
    Posted
    December 30, 2006
    Terminated
    August 9, 2007
    Address
    150 Minuteman Drive, Andover, MA, 01810-1031

    Description

    TruFit BGS Plug Size Code Blue, 9mm; quantity 1; Part #600-001-05; product labeled as sterile; manufactured by OsteoBiologics, Inc., San Antonio, TX.

    Reason

    Mis-packaging-product in the package may be a different size than indicated on the labeling.

    Action

    Firm notified customers of recall by letter sent via FedEx on 09/29/06.

    Distribution

    Nationwide-Product distributed to distributors, sales reps and hospitals in AL, CA, FL, IL, NJ, NM, NY, PA, TX and UT.

    Quantity

    34