Tritanium X recallZ-1437-2021 · Stryker Spine · initiated Mar 11, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Spine or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1437-2021
- Status
- Terminated
- Initiated by the company
- Mar 11, 2021
- Recalling firm
- Stryker Spine
- Quantity
- 169 sets
- Product code
- MAX
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, GA, KY, MA, MT, NC, NE, NJ, NY, OH, PA, WY.
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).
Code information (models, lots, serial numbers)
(UDI): 07613327366310, 07613327366839680220102, 07613327366884, 07613327366457
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- Tritanium X 580220101Stryker Corporation · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 recall2 reports
- Tritanium X 580220100Stryker Corporation · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 recall1 report
- Tritanium X 680220102Stryker Corporation · Intervertebral fusion device with bone graft, lumbar1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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