BEUDAMED
    FDA Recall 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 · Initiated March 11, 2021

    Recall

    Recall Number
    Z-1437-2021
    Event Number
    87580
    Firm
    Stryker Spine
    FEI Number
    3004024955
    Product Code
    MAX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 11, 2021
    Terminated
    January 5, 2023
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611

    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.

    Action

    On 03/17/2021, Stryker issued an Urgent Medical Device Recall notice to customers and distributers via letter because the firm identified non-conforming components of the Titanium X TL sets which could lead to device failure in the field.

    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