FDA Device recall Z-1963-2017
GREEN ROTATING CRANIOTOME, BLACK MAX
- FDA Device
- Class II
- terminated
- Published 2017-05-10
On 2017-05-10 the FDA classified a Class II recall of GREEN ROTATING CRANIOTOME, BLACK MAX by The Anspach Effort, citing supplied Directions for Use (DFU) did not contain a recommended service interval.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1963-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-06 |
| Published | 2017-05-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | The Anspach Effort |
| Distribution | US |
Product
GREEN ROTATING CRANIOTOME, BLACK MAX
Reason
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Identifiers
| code_info | All serial numbers shipped to customers; DFU 18-0062; Part No. B-GREEN-R. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1963-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.