Recall Z-1437-2021— Stryker Spine
Class II · Terminated
Class II FDA medical device recall by Stryker Spine, initiated 2021-03-11, terminated 2023-01-05. FDA's recall record names no specific 510(k) clearance for this event. 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).. 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..
- Recalling firm
- Stryker Spine
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-03-11
- Terminated
- 2023-01-05
- Firm location
- Allendale, NJ, United States
Product 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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.