BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1029-2019 · Initiated February 19, 2019

    Recall

    Recall Number
    Z-1029-2019
    Event Number
    82193
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    February 19, 2019
    Terminated
    May 21, 2021
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    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"

    Action

    The firm notified its direct accounts by email and letter on 02/18/2019. The notice requested return of the recalled products. Distributors were directed to notify their customers of the recall and ensure that the actions are carried out.

    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