BEUDAMED
    FDA Recall Terminated

    GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic

    Recall: Z-0131-2014 · Initiated October 7, 2013

    Recall

    Recall Number
    Z-0131-2014
    Event Number
    66545
    Firm
    Smith & Nephew Inc
    FEI Number
    1020279
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 7, 2013
    Posted
    November 1, 2013
    Terminated
    August 23, 2016
    Address
    1450 E. Brooks Rd, Memphis, TN, 38116

    Description

    GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic

    Reason

    Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.

    Action

    Smith & Nephew sent an Urgent - Product Recall 1st Notification letter to all affected sales staff via email and FedEx on October 7, 2013. The hospital was notified by sales rep on October 9, 2013 and the notification letter was sent to the hospital via Fed Ex on October 11, 2013. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory, discontinue use, quarantine affected products immediately and return to Smith & Nephew. Customers were asked to complete the attached Inventory Return Certification Form and fax to 901-566-7975.

    Distribution

    USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.

    Quantity

    4 units