FDA Device recall Z-0715-2014
Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
- FDA Device
- Class II
- terminated
- Published 2014-01-22
On 2014-01-22 the FDA classified a Class II recall of Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures by The Anspach Effort, citing current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0715-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-03-29 |
| Published | 2014-01-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | The Anspach Effort |
| Distribution | US |
Product
Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
Reason
Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs.
Identifiers
| code_info | ALL LOTS for product code 18-0001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0715-2014%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.