Anspach Pneumatic and Electric Motor Systems — Class II medical device recall Z-1983-2014
Terminated recall by The Anspach Effort, Inc., reported 2014-07-09, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized
| Recall number | Z-1983-2014 |
|---|---|
| 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 | 2014-05-08 |
| Classified | 2014-07-03 |
| Reported by FDA | 2014-07-09 |
| Terminated | 2016-01-29 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CR, CZ, DE, DO, EG, ES, FI, FR, GB, HK, IL, IN, JM, JP, KR, KY, LT, MX, MY, NG, NL, PA, PL, PT, SA, SE, SG, TH, TR, VE, ZA |
| Quantity | 115,988 units |
| Reason classes | sterility |
Product
Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.
Reason for recall
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.
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-1983-2014. 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.