Device recall
Z-0083-2010: Foot Pedal, Foot Control for SC2000 and SC2100 Powered, simple cranial drills…
FDA device recall · Class II · The Anspach Effort, Inc.
Key facts
| Recall number (Z-number) | Z-0083-2010 |
|---|---|
| Recall event | 53073 |
| Product | Foot Pedal, Foot Control for SC2000 and SC2100 Powered, simple cranial drills, burrs, trephines, and their accessories. Catalog Numbers: EMAX2-FP and FPLUS-FP. Indicated to cut and shape bone including bones of the spine and cranium. |
| Product code | HBE |
| Recalling firm | The Anspach Effort, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 5, 2010 |
| 510(k) numbers | K011444, K080802 |
| FEI number | 1045834 |
At a glance
- 1–9 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