Z-1437-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 28, 2021
- Initiation Date
- March 11, 2021
- Termination Date
- January 5, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 169 sets
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.
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, CO, GA, KY, MA, MT, NC, NE, NJ, NY, OH, PA, WY.
Code Information
(UDI): 07613327366310, 07613327366839680220102, 07613327366884, 07613327366457