Anspach recalls 7.5 cm Craniotome Attachment for possible ball bearing dislodgement during surgery, risking serious patient injury if not inspected regularly.
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
Anspach is recalling their 7.5 cm Large Craniotome Attachment for use with XMax, microMax, and eMax systems. The recall is due to a risk of serious patient injury if ball bearings become dislodged during removal of the attachment.
Ball bearings inside the attachment may become dislodged during removal, potentially causing serious injury to patients during surgery. Failure to follow the manufacturer's recommended inspection intervals increases this risk.
Surgical teams using the 7.5 cm Craniotome Attachment with Anspach's XMax, microMax, or eMax systems are most at risk. Patients undergoing surgery with this attachment could face serious injury if the ball bearings dislodge.
Check for the 7.5 cm Large Craniotome Attachment labeled 'CRANI-L' used with XMax, microMax, or eMax systems. All lots are affected, so no specific model or date range is needed.
Inspect the attachment for any dislodged ball bearings before use. If found, stop using the attachment immediately.
Adhere to the manufacturer's recommended inspection intervals to prevent dislodgement of ball bearings.
The product may pose a risk of serious injury if ball bearings dislodge during use. Always follow the manufacturer's inspection intervals to minimize risk.
The manufacturer recommends following specific inspection intervals, but the exact frequency is not stated in the recall notice.
The recall notice does not specify a return process, so contact Anspach directly for guidance.
We’ve drafted a message you can send Anspach to request your refund or repair — edit it as you like.
Subject: Recall Z-0920-2023 — Anspach Anspach Hello, I own a Anspach that is covered by recall Z-0920-2023 from Anspach. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
