BEUDAMED
    FDA Recall Terminated

    Surgical Pattie, 1/4" x 1/4" Non--Sterile (Each Unit of sales is 100 cards) of patties on each card) Product code: 24-5403

    Recall: Z-0095-2011 · Initiated July 16, 2010

    Recall

    Recall Number
    Z-0095-2011
    Event Number
    56279
    Firm
    Codman & Shurtleff, Inc.
    FEI Number
    3002947440
    Product Code
    HBA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 16, 2010
    Posted
    October 20, 2010
    Terminated
    July 9, 2012
    Address
    325 Paramount Drive, Raynham, MA, 02767

    Description

    Surgical Pattie, 1/4" x 1/4" Non--Sterile (Each Unit of sales is 100 cards) of patties on each card) Product code: 24-5403

    Reason

    Surgical Pattie x-ray stripe (radio-opaque marker) may become detached

    Action

    Codman notified customers by letter dated 7/16/10 issued July 23 through July 26, 2010 via Fed'x overnight advising users that the x-ray marker on Codman Surgical Patties may become detached. Customers are instructed to return product from affected lots. An error in the original letter was discovered and a corrected letter dated July 28, 2010 issued. If there are any questions, please contact Codman at (800) 225-0460.

    Distribution

    Nationwide Foreign: Canada, Singapore, Belgium, Mexico, Madrid, Dubai, Tokyo, Brazil, New Zealand, Egypt, South Africa, Singapore,

    Quantity

    229 boxes (100 cards/10 patties each card)