Device recall
Z-0767-2014: MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Intended…
FDA device recall · Class II · The Anspach Effort, Inc.
Key facts
| Recall number (Z-number) | Z-0767-2014 |
|---|---|
| Recall event | 63624 |
| Product | MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. |
| Product code | HBE |
| Recalling firm | The Anspach Effort, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 11, 2015 |
| 510(k) numbers | K042783 |
| FEI number | 1045834 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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