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 | Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the current Directions for Use (DFU) provided with the device. |
| Product | Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium. |
| Quantity | 115,988 units |
| Distribution | Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,UT, VA, VT, WA, WI, WV, WY, and Hawaii, and the territories of Puerto Rico, US Virgin Island and Guam; and, the countries of Argentina, Australia, Austria, Belgium, Brazil, Came… |
| Initiated | 2014-05-08 |
| Classified | 2014-07-03 |
| Terminated | 2016-01-29 |
| Recall number | Z-1983-2014 |
| 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-1983-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68496/
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