BEUDAMED
    FDA Enforcement Class II Terminated

    3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 01 The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.

    Recall: Z-2659-2017 · Reported July 12, 2017

    Enforcement

    Recall Number
    Z-2659-2017
    Event ID
    77435
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Encore Medical, Lp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 12, 2017
    Initiation Date
    May 31, 2017
    Classification Date
    June 30, 2017
    Termination Date
    January 8, 2021
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    Description

    3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 01 The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.

    Reason

    Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert.

    Code Info

    Lot # 339G1045

    Distribution

    Worldwide Distribution-US (nationwide) to states of: AL, TX, UT, and CA; and countries of: INDIA and GERMANY.

    Quantity

    9 units