FDAMarch 11, 2021device
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).
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
stryker spinestryker
UPCs
076133273663100761332736688407613327366457
Recall history
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