Anspach recalls CRANI-A-G1 craniotome attachments due to potential ball bearing dislodgement during use, risking serious patient injury if inspection intervals are not 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 its CRANI-A-G1 adult craniotome attachments because ball bearings can become dislodged during removal, potentially causing serious injury if not inspected regularly. This is a medical device used for bone surgery, so affected users must follow the manufacturer's inspection guidelines to prevent harm.
Ball bearings inside the CRANI-A-G1 attachment can become dislodged when removing the attachment, especially if not inspected as recommended. This could lead to serious injury during surgery if the bearings cause unintended damage to the patient's bones or tissues.
Medical professionals who use the CRANI-A-G1 craniotome attachments for bone surgery are most at risk. Patients undergoing procedures with this device could be affected if the attachment fails during surgery.
Check for the CRANI-A-G1 model number on the attachment. The product was sold with the GTIN 00845384016410 and is available for all lots.
Check the CRANI-A-G1 attachment for any signs of dislodged ball bearings before each use.
Adhere to the manufacturer's recommended inspection schedule to prevent ball bearing dislodgement.
The product is safe if inspected regularly as per the manufacturer's guidelines. Failure to follow inspection intervals may cause serious injury.
Look for the CRANI-A-G1 model number on the attachment. The product was sold with GTIN 00845384016410 across all lots.
Inspect the attachment for dislodged ball bearings before each use and follow the manufacturer's recommended inspection intervals.
We’ve drafted a message you can send Anspach to request your refund or repair — edit it as you like.
Subject: Recall Z-0918-2023 — Anspach Anspach Hello, I own a Anspach that is covered by recall Z-0918-2023 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.
