Device recall
Z-0545-2015: McKenzie Perforator Drills are bone cutting and drilling instruments that are…
FDA device recall · Class II · Instrumed International, Inc.
Key facts
| Recall number (Z-number) | Z-0545-2015 |
|---|---|
| Recall event | 69471 |
| Product | McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Phoenix Instruments, Stealth Surgical, CareFusion, and Boss Instruments brand names. |
| Product code | HBG |
| Recalling firm | Instrumed International, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 29, 2017 |
| FEI number | 1421101 |
At a glance
- None Linked 510(k)s
- 10–99 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