BEUDAMED
    FDA Recall Terminated

    GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis

    Recall: Z-2883-2018 · Initiated August 1, 2017

    Recall

    Recall Number
    Z-2883-2018
    Event Number
    80752
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    August 1, 2017
    Terminated
    February 19, 2019
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis

    Reason

    Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left.

    Action

    The firm notified its consignees of the problem and the recall by email on 08/01/2018. The firm requested the return of the product.

    Distribution

    Australia, Austria, Germany, Great Britain, Poland, Spain

    Quantity

    27 units