Adult Craniotome — Class II medical device recall Z-0921-2023
Ongoing recall by The Anspach Effort, Inc., reported 2023-01-18, distributed nationwide. Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, pos
| Recall number | Z-0921-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Anspach Effort, Inc., Palm Beach Gardens, FL, United States |
| Recall initiated | 2022-12-07 |
| Classified | 2023-01-06 |
| Reported by FDA | 2023-01-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, ES, FI, FR, GB, GR, HR, HU, ID, IE, IL, IN, IT, JM, JP, KE, KR, KW, LB, LT, MA, MX, MY, NL, NZ, PA, PE, PH, PL, PT, SA, SE, SG, SK, TH, TR, TW, ZA |
| Quantity | 6,059 units |
| UPC / GTIN / UDI-DI | 00845384016427 |
| Model numbers | CRANI-L-G1 |
Product
Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
Reason for recall
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
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-0921-2023. 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.