Globus Medical recalls cranial drills with potential packaging breaches that could lead to non-sterile instruments. Affected units may have discoloration near the tip. Consumers should contact the company for details.
Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
Globus Medical is recalling cranial drills that may not be sterile due to packaging issues. This could lead to infections if used in surgery. Affected users should stop using the product and contact the manufacturer.
The packaging may have been breached, allowing contaminants to enter the sterile instruments. Discoloration near the drill tip could indicate improper sterilization, potentially causing infections during surgery.
Surgical teams and hospitals using Globus Medical cranial drills with specific model numbers. Patients undergoing surgery are at risk if the non-sterile drills are used.
Check for model numbers starting with 6143.1834S or lot numbers listed in the recall notice. The product is sold with the ExcelsiusGPS system.
Identify the model number and lot number on the instrument to confirm if it's affected.
Reach out to Globus Medical for specific instructions on whether the product is affected and what to do next.
The recall is due to potential packaging breaches that could lead to non-sterile instruments, increasing infection risk during surgery.
Check for model numbers starting with 6143.1834S or lot numbers listed in the recall notice.
Contact Globus Medical directly for specific instructions on whether to stop using the product and what steps to take.
We’ve drafted a message you can send Globus Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0995-2024 — Globus Medical Globus Medical Hello, I own a Globus Medical that is covered by recall Z-0995-2024 from Globus Medical. 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.
