Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0924-2023 — Pediatric Craniotome Ref:CRANI-P-G1

U.S. FDA — Device Enforcement · United States · 2022-12-07 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0924-2023
Date of alert
2022-12-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
The Anspach Effort, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00845384016403
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.