Device recall
Z-0468-2011: CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011
FDA device recall · Class II · Orthohelix Surgical Designs Inc
Key facts
| Recall number (Z-number) | Z-0468-2011 |
|---|---|
| Recall event | 57095 |
| Product | CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011 |
| Product code | HWX |
| Recalling firm | Orthohelix Surgical Designs Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 6, 2012 |
| 510(k) numbers | K060428 |
| FEI number | 3000718467 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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