Device recall
Z-2381-2012: The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a…
FDA device recall · Class II · Integra Life Sci.
Key facts
| Recall number (Z-number) | Z-2381-2012 |
|---|---|
| Recall event | 62728 |
| Product | The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to prepare oriented holes in bone for insertion of a Standard Surfix Locking Screw with plates for the Tiblaxis, Uni-CP, Advansys MLP and Advansys DLP compression plate systems. The Drilling Guides are initially… |
| Product code | FZX |
| Recalling firm | Integra Life Sci. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 20, 2013 |
| FEI number | 3003418325 |
At a glance
- None 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