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).
This recall has been terminated (originally issued March 11, 2021).
- Company
- Stryker Spine
- Recall Initiated
- March 11, 2021
- Terminated
- January 5, 2023
- Recall Number
- Z-1437-2021
- Quantity
- 169 sets
- Firm Location
- Allendale, NJ
- Official Source
- View on FDA website ↗
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
US Nationwide distribution in the states of AZ, CA, CO, GA, KY, MA, MT, NC, NE, NJ, NY, OH, PA, WY.
Lot / Code Info
(UDI): 07613327366310, 07613327366839680220102, 07613327366884, 07613327366457
Root Cause
Device Design
Action Taken
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.