Recall Z-1437-2021
Stryker Spine · initiated March 11, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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).
Codes / lots: (UDI): 07613327366310, 07613327366839680220102, 07613327366884, 07613327366457
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.
FDA-determined 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.
Details
- Recall number
- Z-1437-2021
- Initiated
- March 11, 2021
- Terminated
- January 5, 2023
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Quantity
- 169 sets
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, GA, KY, MA, MT, NC, NE, NJ, NY, OH, PA, WY.
- Recalling firm
- Stryker Spine, Allendale, NJ