Anspach recalls 6.5 cm Adult Rotating Craniotome Attachments used with XMax, microMax, and eMax systems due to potential ball bearing dislodgement during use, which could cause 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 6.5 cm Adult Rotating Craniotome Attachments that come with XMax, microMax, and eMax systems. These attachments may have ball bearings that come loose during removal or surgery, risking serious injury to patients if not properly checked as per the manual.
Ball bearings in the CRANI-A attachment may become dislodged during removal or surgery. If not inspected regularly as recommended in the manual, this could lead to serious patient injury.
Surgical teams using Anspach's CRANI-A attachments with XMax, microMax, or eMax systems are most at risk. Patients undergoing bone surgery with these attachments could face serious injury if the device fails during use.
Check for the CRANI-A label on the attachment. It is used with XMax, microMax, or eMax systems and intended for bone cutting and shaping. All lots are affected.
Inspect the CRANI-A attachment for any loose ball bearings before use, as per the manufacturer's instructions.
No, this recall specifically affects the CRANI-A attachment used with XMax, microMax, and eMax systems for bone cutting and shaping procedures.
The manufacturer recommends following the inspection intervals provided in the instructions for use to prevent serious injury.
No, you must check for loose ball bearings before each use to avoid serious injury during surgery.
We’ve drafted a message you can send Anspach to request your refund or repair — edit it as you like.
Subject: Recall Z-0916-2023 — Anspach Anspach Hello, I own a Anspach that is covered by recall Z-0916-2023 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.
