Use cautionMedical device recall · FDA · Published March 11, 2021
Stryker Tritanium X TL Instruments Recall: Risk of Device Failure During Surgery
Stryker Spine recalls specific lumbar intervertebral fusion instruments due to potential device failure during spinal surgery. Affected items include TL Inserter, Draw Rod, and Syringe Plunger components with UDI codes listed.
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.
Take action
Contact the company
📍Recalling firmStryker Spine2 Pearl Ct · Allendale, NJ 07401-1611
“Stryker Tritanium X TL Instruments Recall: Risk of Device Failure During Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63102-stryker-tritanium-x-tl-instruments-recall-risk-of-device-failure. Based on FDA recall #Z-1437-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1437-2021%22&limit=1).
The FDA announced on March 11, 2021, that Stryker Spine is recalling Tritanium X TL Instruments due to non-conforming components that could lead to device failure during a procedure. The agency issued recall number Z-1437-2021 for the Class II voluntary recall.
How to tell if you have it
Brand: Stryker Spine
Product: Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar
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.
Context
GovInfoNow's records show Stryker Spine has 5 other recalls on record since August 13, 2018. Other recent recalls of similar products include the Monterey AL Implant Inserter Recall (February 28, 2025), the AVS Anchor-C Cervical Cage System labeling correction recall (August 23, 2024), and the LITe Decompression Snake Arm Recall (November 1, 2023). Other recent recalls of similar products include the Surgify Halo 4.0mm Short Model 40.170.NVG.U1 recall (April 30, 2026) and the Stryker XCEL Bladeless Trocar W/Stability Sleeve 12x100mm and W/Optiview recalls (August 19, 2026).
How to tell if you have this one
Check for the specific UDI codes: 07613327366310, 07613327366839680220102, 07613327366884, or 07613327366457. The instruments include TL Inserter, Draw Rod, Tube Set/Syringe Adapter Assembly, and Syringe Plunger.
Brand
Stryker Spine
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check UDI Codes
Look for the specific UDI codes listed in the recall: 07613327366310, 07613327366839680220102, 07613327366884, or 07613327366457.
Contact Stryker Spine
Reach out to Stryker Spine directly for further instructions on handling the recalled instruments.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 14 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AZ, CA, CO, GA, KY, MA, MT, NC, NE, NJ, NY, OH, PA, WY.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Georgia, Kentucky, Massachusetts, Montana, Nebraska, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Wyoming.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1437-2021 (March 11, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1437-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.