BEUDAMED
    FDA Recall Terminated

    Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm

    Recall: Z-0085-2022 · Initiated September 2, 2021

    Recall

    Recall Number
    Z-0085-2022
    Event Number
    88684
    Firm
    Medtronic Sofamor Danek USA Inc
    FEI Number
    1000477302
    Product Code
    OVD
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    September 2, 2021
    Terminated
    October 5, 2023
    Address
    1800 Pyramid Pl, Memphis, TN, 38132-1703

    Description

    Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm

    Reason

    Engraving on implants may not match what is listed on the pouch labels.

    Action

    A customer letter was sent via FedEx to impacted US consignees and delivered on or about September 3, 2021. Customers are asked to locate and remove the impacted product from normal storage locations. Customers are advised to not use product. A Customer Confirmation Form should be completed and returned to [email protected]. Customers may also coordinate return and replacement of impacted product with the Medtronic Sales Representative. This recall notice should be forwarded to those within the customer organization or to any organization where potentially impacted devices have been transferred.

    Distribution

    Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV

    Quantity

    10 units