BEUDAMED
    FDA Recall Terminated

    12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS.

    Recall: Z-2427-2012 · Initiated August 22, 2012

    Recall

    Recall Number
    Z-2427-2012
    Event Number
    63089
    Firm
    Smith & Nephew Inc
    FEI Number
    1020279
    Product Code
    MEH
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    August 22, 2012
    Posted
    September 20, 2012
    Terminated
    February 27, 2013
    Address
    1450 E. Brooks Rd, Memphis, TN, 38116

    Description

    12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS.

    Reason

    Modular necks were manufactured out of specification by a vendor; the taper provide is undersized.

    Action

    Smith & Nephew sent an "URGENT:CLASS II RECALL-HIGH OFFSET MODULAR NECK R1213 letter dated August 22, 2012 to all affected customers. The letter identified the product, problem, and the actions to be taken by the customers. Customers were instructed to cease use and distribution of the product and quarantine for return. An Inventory Return Certification Form was included for customers to complete and return via fax to 901-566-7975.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of CA, FL, GA, IL, IN, MA, NC, NJ, NY, OH, OK, PA, TN, TX, and WA, and the country of Canada.

    Quantity

    70 units