Device recall
Z-0207-2019: Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product…
FDA device recall · Class II · Howmedica Osteonics Corp.
Key facts
| Recall number (Z-number) | Z-0207-2019 |
|---|---|
| Recall event | 81096 |
| Product | Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrument which is provided in a non-sterile condition. The inserter is designed to enter the disc space, with a fixed engagement between the inserter and the cage and then… |
| Product code | LXH |
| Recalling firm | Howmedica Osteonics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 16, 2020 |
| 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