Stryker Spine: Medical Device Recall in 2021 - (Recall #: Z-1437-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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).

Product Classification:

Class II

Date Initiated: March 11, 2021

Date Posted: April 28, 2021

Recall Number: Z-1437-2021

Event ID: 87580

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.

Status: Terminated

Product Quantity: 169 sets

Code Information:

(UDI): 07613327366310, 07613327366839680220102, 07613327366884, 07613327366457

Distribution Pattern:

US Nationwide distribution in the states of AZ, CA, CO, GA, KY, MA, MT, NC, NE, NJ, NY, OH, PA, WY.

Voluntary or Mandated:

Voluntary: Firm initiated