Anspach recalls 6.5 cm Adult Rotating Craniotome Attachment (CRANI-A-R) used with XMax, microMax, and eMax systems. Ball bearings may dislodge during use, risking serious patient injury if not inspected per instructions.
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 Adult Rotating Craniotome Attachment (CRANI-A-R) because ball bearings can come loose during removal or surgery, potentially causing serious injury to patients if not checked regularly.
Ball bearings inside the CRANI-A-R attachment can become dislodged during removal or surgery. If not inspected according to the manufacturer's instructions, this could lead to serious injury to patients during procedures.
Surgical professionals using the CRANI-A-R attachment with Anspach's XMax, microMax, or eMax systems are most at risk. Patients undergoing surgery with this attachment could be injured if the device fails.
The CRANI-A-R attachment is a 6.5 cm adult rotating craniotome used with Anspach's XMax, microMax, or eMax systems. It was sold with the GTIN 00845384001744 and all production lots.
Inspect the attachment for any dislodged ball bearings before use, following the manufacturer's recommended inspection intervals.
The product may pose a serious injury risk if ball bearings become dislodged during use or removal. Regular inspections as per the manufacturer's instructions are required to ensure safety.
The manufacturer recommends following the inspection intervals provided in the instructions for use (IFU) to prevent serious injury.
If loose ball bearings are found, stop using the attachment immediately 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-0919-2023 — Anspach Anspach Hello, I own a Anspach that is covered by recall Z-0919-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
