Anspach recalls 6.5 cm Adult Craniotome Thin Foot Plate Attachment used with XMax, microMax, and eMax systems. Ball bearings may dislodge during use, risking serious patient injury if inspection intervals aren't followed.
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 a 6.5 cm adult craniotome thin foot plate attachment for use with specific surgical systems. The recall is due to a risk of ball bearings dislodging during removal, which could cause serious injury if proper inspection intervals aren't followed.
Ball bearings inside the attachment can become dislodged during removal or surgical use. If these bearings are not properly checked as per the manufacturer's instructions, they could cause serious injury to patients during surgery.
Medical professionals using the craniotome attachment with XMax, microMax, or eMax systems are affected. Those who have not followed the recommended inspection intervals are at higher risk.
This attachment has a 6.5 cm size and is used with XMax, microMax, or eMax surgical systems. It was sold with the reference number CRANI-A-01 and is intended for bone cutting by trained medical personnel.
Follow the manufacturer's recommended inspection intervals to ensure ball bearings remain secure before use.
The product is safe only if the recommended inspection intervals are followed. Failure to do so may cause serious injury.
Ball bearings may dislodge during removal or surgical use, potentially causing serious injury if not properly inspected.
This product is a 6.5 cm adult craniotome thin foot plate attachment used with XMax, microMax, or eMax systems, with reference number CRANI-A-01.
We’ve drafted a message you can send Anspach to request your refund or repair — edit it as you like.
Subject: Recall Z-0917-2023 — Anspach Anspach Hello, I own a Anspach that is covered by recall Z-0917-2023 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.
