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

Recall Z-0923-2023 — 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

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

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0923-2023
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)
00845384001775
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.

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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.