BEUDAMED
    FDA Enforcement Class II Terminated

    Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube Set/Syringe Adapter Assembly (680220100), Syringe Plunger (680220102).

    Recall: Z-1437-2021 · Reported April 28, 2021

    Enforcement

    Recall Number
    Z-1437-2021
    Event ID
    87580
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Spine
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 28, 2021
    Initiation Date
    March 11, 2021
    Classification Date
    April 20, 2021
    Termination Date
    January 5, 2023
    Address
    2 Pearl Ct, N/A, Allendale, NJ, 07401-1611, United States

    Description

    Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube Set/Syringe Adapter Assembly (680220100), Syringe Plunger (680220102).

    Reason

    Stryker identified non-conforming instruments that are components of the Tritanium X TL sets. The firm found non-conformances with the TL Inserter, TL Draw Rod, Tube Set/Syringe Adapter Assembly, and Syringe Plunger that could lead to device failure during a procedure.

    Code Info

    (UDI): 07613327366310, 07613327366839680220102, 07613327366884, 07613327366457

    Distribution

    US Nationwide distribution in the states of AZ, CA, CO, GA, KY, MA, MT, NC, NE, NJ, NY, OH, PA, WY.

    Quantity

    169 sets