Anspach recalls pediatric craniotome Ref CRANI-P-G1 due to risk of serious injury from ball bearings dislodging during use. All units are affected. Contact for remedy.
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 all pediatric craniotomes with model CRANI-P-G1 because ball bearings can come loose during surgery, potentially causing serious injury to patients. This is a critical safety issue that requires immediate attention from medical professionals using the device.
The craniotome attachment has ball bearings that can become dislodged during removal or surgery. If not checked regularly as per the manufacturer's instructions, these bearings may cause serious injury to patients.
Medical professionals who use the Anspach Pediatric Craniotome Ref CRANI-P-G1 are affected. Patients undergoing surgery with this device are at risk of serious injury if the ball bearings dislodge.
Check for the model number CRANI-P-G1 on the craniotome. All units produced by Anspach are affected, with no specific lot numbers listed.
Immediately stop using the pediatric craniotome if it has the model CRANI-P-G1 as it poses a serious injury risk during surgery.
No, only the specific model CRANI-P-G1 is affected.
Look for the model number CRANI-P-G1 on the device. All units are affected with no specific lot numbers.
Immediately stop using it 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-0924-2023 — Anspach Anspach Hello, I own a Anspach that is covered by recall Z-0924-2023 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.
