FDA Device recall Z-0923-2023
6.5 cm Pediatric Craniotome Attachment
- FDA Device
- Class II
- ongoing
- Published 2023-01-18
On 2023-01-18 the FDA classified a Class II recall of 6.5 cm Pediatric Craniotome Attachment by The Anspach Effort, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0923-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-07 |
| Published | 2023-01-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | The Anspach Effort |
| Distribution | US |
Product
6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium
Reason
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
Identifiers
| code_info | GTIN: 00845384001775 All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0923-2023%22
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