Anspach recalls adult craniotomes (CRANI-L-G1) due to ball bearings potentially falling out during use, 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 adult craniotomes (CRANI-L-G1) because ball bearings can fall out during use, which may cause serious injury if the device isn't inspected as recommended. This is a medical device used for bone surgery.
Ball bearings inside the craniotome attachment can become dislodged during removal or surgery. If not checked regularly as per the manufacturer's instructions, these bearings could cause serious injury to patients during procedures.
Medical professionals who use the CRANI-L-G1 craniotome for bone surgery are most at risk. Patients undergoing spinal or cranium procedures could be affected if the device is used without proper inspection.
Check for the product name 'Adult Craniotome, Large' with reference number CRANI-L-G1. This device was sold with the GTIN 00845384016427 and is used for bone surgery including spinal and cranium procedures.
Inspect the craniotome attachment for any dislodged ball bearings before use.
Adhere to the manufacturer's recommended inspection schedule to prevent serious injury.
The device is safe only if ball bearings are checked regularly as per the manufacturer's instructions. Failure to do so may cause serious injury.
The manufacturer recommends following the inspection intervals provided in the user manual, but the specific frequency is not stated in this recall notice.
Not following the inspection steps could result in serious patient injury due to dislodged ball bearings.
We’ve drafted a message you can send Anspach to request your refund or repair — edit it as you like.
Subject: Recall Z-0921-2023 — Anspach Anspach Hello, I own a Anspach that is covered by recall Z-0921-2023 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.
