Device recall
Z-1437-2021: Tritanium X TL Instruments - intervertebral fusion device with bone graft…
FDA device recall · Class II · Stryker Spine
Key facts
| Recall number (Z-number) | Z-1437-2021 |
|---|---|
| Recall event | 87580 |
| 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). |
| Product code | MAX |
| Recalling firm | Stryker Spine |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 5, 2023 |
| FEI number | 3004024955 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database