Anspach recalls 7.5 cm Large Rotating Craniotome Attachments used with XMax, microMax, and eMax systems due to risk of ball bearings dislodging during surgery, potentially causing serious patient injury. All units are affected.
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 its 7.5 cm Large Rotating Craniotome Attachment for use with XMax, microMax, and eMax systems. The recall is because ball bearings inside the attachment can become dislodged during removal or surgery, which could cause serious injury to patients.
Ball bearings inside the attachment can become dislodged during removal or surgery. If not inspected as recommended, these bearings could cause serious injury to patients during medical procedures.
Surgical teams using the Anspach 7.5 cm Large Rotating Craniotome Attachment with XMax, microMax, or eMax systems are affected. Patients undergoing surgery with this attachment are at risk of serious injury.
This product is labeled '7.5 cm Large Rotating Craniotome Attachment' and is used with XMax, microMax, or eMax systems. All lots are affected, so every unit is included in this recall.
Immediately stop using the 7.5 cm Large Rotating Craniotome Attachment with XMax, microMax, or eMax systems as it poses a serious injury risk.
No, the product is not safe to use as ball bearings can become dislodged during removal or surgery, potentially causing serious injury.
Look for the product labeled '7.5 cm Large Rotating Craniotome Attachment' used with XMax, microMax, or eMax systems. All lots are affected.
Immediately stop using it now and contact Anspach for further instructions.
We’ve drafted a message you can send Anspach to request your refund or repair — edit it as you like.
Subject: Recall Z-0922-2023 — Anspach Anspach Hello, I own a Anspach that is covered by recall Z-0922-2023 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.
