BEUDAMED
    FDA Recall Terminated

    Genesis Uni Articular Inserts

    Recall: Z-0304-05 · Initiated June 21, 2004

    Recall

    Recall Number
    Z-0304-05
    Event Number
    29816
    Firm
    Smith & Nephew Inc
    FEI Number
    1020279
    Product Code
    HSX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 21, 2004
    Posted
    December 14, 2004
    Terminated
    February 15, 2006
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    Genesis Uni Articular Inserts

    Reason

    The firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively.

    Action

    Recall notification was initiated by letter (Fed Ex) to domestic territory manager and sales representative and to international distributors (via email) on 06/21/2004 to request the return of any in stock product.

    Distribution

    Nationwide, 43 consignees, 17 countries: Germany, France, Australia, Italy, Switzerland, United Arab Emirates, Belgium, Japan, United Kingdom, Singapore, Spain, Taiwan. Sweden, Canada Venezuela, South Africa, and Israel.

    Quantity

    11,339 units were distributed