# FDA recall Z-1437-2021

> **Stryker Spine** · Class II · device recall initiated 2021-03-11.

## 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 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.

## Key facts

- **Recall number:** Z-1437-2021
- **Recalling firm:** Stryker Spine
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-11
- **Report date:** 2021-04-28
- **Termination date:** 2023-01-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allendale, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1437-2021

## Citation

> AI Analytics. FDA recall Z-1437-2021. Retrieved 2026-08-12 from https://api.ai-analytics.org/recall/Z-1437-2021. Source: US FDA. Licensed CC0.

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