Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿ Recalled by The Anspach Effort, Inc. Due to Ball bearings in the CRANI-A (ANSPACH Power Tools...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact The Anspach Effort, Inc. directly.
Affected Products
7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium
Quantity: 6059 units in total
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About The Anspach Effort, Inc.
The Anspach Effort, Inc. has 261 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report