BEUDAMED
    FDA Recall 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 · Initiated May 31, 2017

    Recall

    Recall Number
    Z-2659-2017
    Event Number
    77435
    FEI Number
    1000116912
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    May 31, 2017
    Terminated
    January 8, 2021
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758-5445

    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.

    Action

    The firm, DJO Global, sent an "URGENT FIELD SAFETY NOTICE" dated 5/31/2017 by email to its consignees on 5/31/2017. The notice described the product, problem and actions to be taken. The consignees were instructed to do the following actions by June 16, 2017: pass notice on to all those within the organization or to any organization where the affected product has been transferred; contact customer service at 1-800-456-8696 to place a replacement order and obtain shipment information; return all affected devices; and complete, sign and return the Acknowledgment and Receipt Form by email to: [email protected]. The Regulatory Affairs department will follow-up via phone and email with non-responding consignees. If you have any questions, please contact Sr. Director Regulatory Affairs by phone at (760) 734-3551 or by email at [email protected].

    Distribution

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

    Quantity

    9 units