Drug recall
Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter…
FDA recall event 87580 · Class II · Stryker Spine
Key facts
| Event ID | 87580 |
|---|---|
| Recall numbers | Z-1437-2021 |
| Recalling firm | Stryker Spine |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Mar 11, 2021 |
| Report date | Apr 28, 2021 |
| Termination date | Jan 5, 2023 |
| City | Allendale |
| State | NJ |
| Country | United States |
| FEI number | 3004024955 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: