BEUDAMED
    FDA Enforcement Class II Terminated

    NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: Intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution-Rotating Hinge Knee (RHK) System, the Trabecular Metal Augments are for cemented use only. When used with the NexGen Complete Knee Solution-Legacy Constrained Condylar Knee System, the Trabecular Metal Augments are for cementless or cemented use.

    Recall: Z-1325-2015 · Reported April 1, 2015

    Enforcement

    Recall Number
    Z-1325-2015
    Event ID
    70605
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Trabecular Metal Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 1, 2015
    Initiation Date
    February 4, 2015
    Classification Date
    March 26, 2015
    Termination Date
    July 16, 2015
    Address
    10 Pomeroy Rd, Parsippany, NJ, 07054-3722, United States

    Description

    NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: Intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution-Rotating Hinge Knee (RHK) System, the Trabecular Metal Augments are for cemented use only. When used with the NexGen Complete Knee Solution-Legacy Constrained Condylar Knee System, the Trabecular Metal Augments are for cementless or cemented use.

    Reason

    One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.

    Code Info

    20 MM - Part No. 00-5490-034-24, Lot #613574282T 5 MM - Part No. 00549003410, Lot #61357484T

    Distribution

    US Distribution in the state of CA

    Quantity

    1 unit