Class II — The Anspach Effort, Inc.
| Recalling firm | THE ANSPACH EFFORT, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures |
| Quantity | 492 (321 US) |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Great Britain, Australia, Switzerland, Sweden, France, Japan, Spain, Italy, Canada, and Netherlands. |
| Initiated | 2012-03-29 |
| Classified | 2014-01-10 |
| Terminated | 2017-10-12 |
| Recall number | Z-0715-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — The Anspach Effort, Inc. (Z-0715-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67177/
Alerts for THE ANSPACH EFFORT, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.