Skip to content
Recall Observatory FDA recall evidence

Device product

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).

Z-1437-2021

March 11, 2021

Class II

Product summary

Firm
Stryker Spine
Event
Event 87580
Status
Terminated
Classification
Class II
Quantity
169 sets
Official record key
device-enforcement:Z-1437-2021

Official wording

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 information: (UDI): 07613327366310, 07613327366839680220102, 07613327366884, 07613327366457

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.