Rotating Adult Craniotome Product Usage: Pneumatic system — Class II medical device recall Z-1988-2017
Terminated recall by The Anspach Effort, Inc., reported 2017-05-10, distributed nationwide. Supplied Directions for Use (DFU) did not contain a recommended service interval.
| Recall number | Z-1988-2017 |
|---|---|
| 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 | 2016-10-06 |
| Classified | 2017-05-04 |
| Reported by FDA | 2017-05-10 |
| Terminated | 2019-07-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP |
| Quantity | 49 |
Product
Rotating Adult Craniotome Product Usage: Pneumatic system
Reason for recall
Supplied Directions for Use (DFU) did not contain a recommended service interval.
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-1988-2017. 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.