Device recall
Z-2199-2008: Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit…
FDA device recall · Class II · Biomet 3i, Inc.
Key facts
| Recall number (Z-number) | Z-2199-2008 |
|---|---|
| Recall event | 48677 |
| Product | Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The product is used for CT guided surgery. |
| Product code | EJB |
| Recalling firm | Biomet 3i, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 15, 2009 |
| FEI number | 1038806 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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