BEUDAMED
    FDA Enforcement Class II Terminated

    smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM, REF 713552511

    Recall: Z-1029-2019 · Reported March 27, 2019

    Enforcement

    Recall Number
    Z-1029-2019
    Event ID
    82193
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 27, 2019
    Initiation Date
    February 19, 2019
    Classification Date
    March 20, 2019
    Termination Date
    May 21, 2021
    Address
    1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States

    Description

    smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM, REF 713552511

    Reason

    Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"

    Code Info

    11CM01091T, 11EM12764T, 11EM12764U, 13MM16036B, 14GM13037D, 15MM09360A, 15MM10833A, 18CM24036 & 18EM15257

    Distribution

    US: CA, TN, NC, AR, IN, FL, MO, and, Canada, China, France, Germany, Great Britain, India, Italy, Japan, Mexico, Poland, South Korea, Spain

    Quantity

    9 units