Anspach MCA Cutting Burr — Class II medical device recall Z-0715-2014
Terminated recall by The Anspach Effort, Inc., reported 2014-01-22, distributed nationwide. Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the
| Recall number | Z-0715-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Anspach Effort, Inc., Palm Beach Gardens, FL, United States |
| Recall initiated | 2012-03-29 |
| Classified | 2014-01-10 |
| Reported by FDA | 2014-01-22 |
| Terminated | 2017-10-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, ES, FR, GB, IT, JP, NL, SE |
Product
Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0715-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.