Device recall
Z-0917-2023: 6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax, microMax…
FDA device recall · Class II · The Anspach Effort, Inc.
Key facts
| Recall number (Z-number) | Z-0917-2023 |
|---|---|
| Recall event | 91231 |
| Product | 6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and cranium by trained medical/surgical personnel |
| Product code | HBC |
| Recalling firm | The Anspach Effort, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K011444, K133604 |
| 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