BEUDAMED
    FDA Enforcement Class II Terminated

    NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 Product Usage: The Trabecular Metal Tibial Cone Augments are 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 Tibial Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments are for cementless or cemented use.

    Recall: Z-1006-2019 · Reported March 20, 2019

    Enforcement

    Recall Number
    Z-1006-2019
    Event ID
    82125
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Trabecular Metal Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 20, 2019
    Initiation Date
    February 1, 2019
    Classification Date
    March 11, 2019
    Termination Date
    May 15, 2020
    Address
    10 Pomeroy Rd, N/A, Parsippany, NJ, 07054-3722, United States

    Description

    NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 Product Usage: The Trabecular Metal Tibial Cone Augments are 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 Tibial Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments are for cementless or cemented use.

    Reason

    Potentially comingled, resulting in the product in the box potentially not matching the product on the label

    Code Info

    Lot Numbers: 63244259 63247617 63279968 61581585T (01) 00889024307902 (17) 210131 (10) 63244259 (01) 00889024307902 (17) 210228 (10) 63247617 (01) 00889024307902 (17) 210228 (10) 63279968 (01) 00889024307902 (17) 210228 (10) 61581585T

    Distribution

    Worldwide Distribution - US Nationwide Distribution in the states of AL, CA, CO, ID, MS,NE, NJ, NY, OH, OR, PA, TX, VA, WI and Foreign CANADA, JAPAN, GERMANY , NETHERLANDS

    Quantity

    26 units