BEUDAMED
    FDA Recall Terminated

    Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the distal femur to prepare the bone to receive a LEGION femoral implant.

    Recall: Z-0200-2019 · Initiated September 18, 2018

    Recall

    Recall Number
    Z-0200-2019
    Event Number
    81100
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    MBH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 18, 2018
    Terminated
    May 8, 2019
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the distal femur to prepare the bone to receive a LEGION femoral implant.

    Reason

    One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.

    Action

    The firm, Smith & Nephew, notified their consignees with a notice entitled " Urgent Medical Device Recall Notice" by email on 09/18/2018. The notice The notice explained the problem and the potential hazard and requested return of the recalled units. The consignees are instructed to do the following: Please inspect your inventory and locate any devices from the listed product and batch numbers on the first page of this Field Action Notification, and quarantine them immediately. a. If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out. 2. If you have no product to return, please put an X in the appropriate location below. 3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes below. 4. Complete the remainders of the form sign and send to [email protected] or fax to 901-566-7975. Please Note even if you have no product to return, this form must be completed, signed and returned. 5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number. If you have any questions or concerns regarding this recall please contact [email protected].

    Distribution

    US Distribution to the states of: KS and TN.

    Quantity

    6 units