BEUDAMED
    FDA Recall 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 · Initiated February 4, 2015

    Recall

    Recall Number
    Z-1325-2015
    Event Number
    70605
    Firm
    Zimmer Trabecular Metal Technology, Inc.
    FEI Number
    3005751028
    Product Code
    MBH
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    February 4, 2015
    Posted
    March 26, 2015
    Terminated
    July 16, 2015
    Address
    10 Pomeroy Rd, Parsippany, NJ, 07054-3722

    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.

    Action

    Zimmer Trabecular Metal Technology sent an email dated 12/10/2014 to their sole customer. The customer was requested to return the affected product.

    Distribution

    US Distribution in the state of CA

    Quantity

    1 unit