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Terminated

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).

FDA Recall Z-1437-2021 · Posted None

Recalling FirmStryker Spine
Recall StatusTerminated
Product CodeMAX
Date Initiated2021-03-11
Date Terminated2023-01-05
Product Quantity169 sets

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.

Firm Action

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.

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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