BEUDAMED
    FDA Recall Terminated

    Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM). Product Usage: Hip joint prosthesis

    Recall: Z-2745-2015 · Initiated June 3, 2015

    Recall

    Recall Number
    Z-2745-2015
    Event Number
    71985
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    NXT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 3, 2015
    Posted
    September 10, 2015
    Terminated
    January 21, 2017
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM). Product Usage: Hip joint prosthesis

    Reason

    The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.

    Action

    Smith & Nephew sent an notification letter dated June 3, 2015 to customers via E-mail and Fed- Ex. The letter identified the affected product, problem and actions to be taken. Customers were asked to quarantine the product and return it. Distributors were asked to notified their customers of the recall and ask them to return the product.

    Distribution

    Worldwide Distribution - US Nationwide and countries of: Australia, Austria, Bahrain (UAE), Belgium, Canada, China, Denmark, Finland, Germany, Hong Kong, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand and United Arab Emirates (UAE).

    Quantity

    5,987 units