BEUDAMED
    FDA Recall 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 · Initiated February 1, 2019

    Recall

    Recall Number
    Z-1006-2019
    Event Number
    82125
    Firm
    Zimmer Trabecular Metal Technology, Inc.
    FEI Number
    3005751028
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    February 1, 2019
    Terminated
    May 15, 2020
    Address
    10 Pomeroy Rd, Parsippany, NJ, 07054-3722

    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

    Action

    Zimmer Biomet notified sent an Urgent Medical Device Recall on February 1, 2019 via email and Fed'X letter to Distributors, hospitals and surgeons, The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately locate and quarantine affected product in your inventory, complete Attachment 1 Inventory Return Certification Form and send to [email protected]. For questions contact Customer Service at 574-371-3071.

    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