Anspach BLACKMAX-N — Class II medical device recall Z-0631-2014
Terminated recall by The Anspach Effort, Inc., reported 2014-01-15, distributed in MD. Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the
| Recall number | Z-0631-2014 |
|---|---|
| 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 | 2012-06-11 |
| Classified | 2014-01-06 |
| Reported by FDA | 2014-01-15 |
| Terminated | 2016-04-18 |
| Distributed | MD |
| Serial numbers | 1934, 3135, 31496704, 50229989-3, 80017906 |
Product
Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.
Reason for recall
Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD).
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-0631-2014. 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.