Anspach recalls 6.5 cm Pediatric Craniotome Attachment used with XMax, microMax, and eMax systems. Ball bearings may dislodge during removal, 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 its 6.5 cm Pediatric Craniotome Attachment for use with XMax, microMax, and eMax systems. Ball bearings can come loose during removal, potentially causing serious injury if not checked as per instructions.
Ball bearings inside the attachment can dislodge during removal or use. If not inspected regularly as recommended, this could lead to serious injury during surgery.
Medical professionals using the attachment for bone cutting procedures are most at risk. Patients undergoing surgery with this device could be affected if the attachment fails.
Check for the 6.5 cm Pediatric Craniotome Attachment labeled 'CRANI-P' used with XMax, microMax, or eMax systems. All lots are affected.
Inspect the attachment for loose ball bearings before each use as per the manufacturer's instructions.
Adhere to the recommended inspection intervals provided in the product's instructions for use to prevent serious injury.
Yes, all lots of the 6.5 cm Pediatric Craniotome Attachment used with XMax, microMax, and eMax systems are affected.
Look for the 'CRANI-P' label on the attachment used with XMax, microMax, or eMax systems. All lots are affected.
Inspect the attachment for loose ball bearings before each use and follow the manufacturer's inspection intervals to prevent serious injury.
We’ve drafted a message you can send Anspach to request your refund or repair — edit it as you like.
Subject: Recall Z-0923-2023 — Anspach Anspach Hello, I own a Anspach that is covered by recall Z-0923-2023 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.
