BEUDAMED
    FDA Recall Terminated

    Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide, 1 1/2" (38 mm) deep, REF 50-8081 sternum retractor

    Recall: Z-1267-2013 · Initiated April 10, 2013

    Recall

    Recall Number
    Z-1267-2013
    Event Number
    64962
    Firm
    Symmetry Medical/SSI
    FEI Number
    3007208013
    Product Code
    DWS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 10, 2013
    Posted
    May 7, 2013
    Terminated
    May 12, 2014
    Address
    3034 Owen Dr, Antioch, TN, 37013-2413

    Description

    Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide, 1 1/2" (38 mm) deep, REF 50-8081 sternum retractor

    Reason

    There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use.

    Action

    Symmetry Surgical sent an Urgent Medical Device Recall letter dated April 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately to determine if they have any of the affected product. If so, customers were instructed to discontinue use of the product immediately and promplty call 800-251-3000 for a return material authorization (RMA) number and to identify if they would like credit or an alternative product. Customers were asked to fill out the attached Recall Response Form and fax the completed form to 615-964-5567. Customers with questions were instructed to call 615-964-5515. For questions regarding this recall call 615-964-5515.

    Distribution

    Worldwide Distribution - USA including CA, MS, FL, PA, TN, CO, IL, TX, OH, MI, MA, IL and internationally to Belgium, Canada, Germany, UK

    Quantity

    524 boxes of 10