BEUDAMED
    FDA Recall Terminated

    GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic

    Recall: Z-1996-2013 · Initiated July 8, 2013

    Recall

    Recall Number
    Z-1996-2013
    Event Number
    65738
    Firm
    Smith & Nephew Inc
    FEI Number
    1020279
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    July 8, 2013
    Posted
    August 22, 2013
    Terminated
    August 19, 2019
    Address
    1450 E. Brooks Rd, Memphis, TN, 38116

    Description

    GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic

    Reason

    The products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts).

    Action

    Smith & Nephew sent an Urgent Recall Notification letter dated July 8, 2013 to all affected customers. Surgeons were notified by letter beginning on July 16, 2013. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory, locate unused devices, quarantine immediately, and return affected product to the address provided in the notification. For questions email to [email protected].

    Distribution

    International only: Germany, France, United Arab Emirates, and United Kingdom.

    Quantity

    9 units