Device recall
Z-0198-2014: Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the…
FDA device recall · Class II · The Anspach Effort, Inc.
Key facts
| Recall number (Z-number) | Z-0198-2014 |
|---|---|
| Recall event | 65863 |
| Product | Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, MicroMax Systems and XMax Motor Systems all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone. |
| Product code | HBC |
| Recalling firm | The Anspach Effort, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 28, 2016 |
| 510(k) numbers | K011444 |
| FEI number | 1045834 |
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