Globus Medical recalls cranial drills with potential packaging breaches that could lead to non-sterile instruments. Affected models include 3.20mm drills with specific UDI codes. Consumers should check product labels for serial numbers and 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 medical procedures. Patients and surgeons using these instruments should stop using them immediately.
The sterile packaging may have been breached, allowing contamination. Discoloration near the drill tip could indicate bacterial growth or other issues that compromise sterility during critical medical procedures.
Medical professionals and patients who use the recalled cranial drills for brain surgery or procedures. Surgeons and hospitals using the affected models are at highest risk.
Check the product label for the model number 3.20mm and the unique device identifier (UDI) codes listed: GBY097VA, GBY097RA, GBY097JA, GBY097HA, GBY097GA, or their RB variants. The product was sold with the ExcelsiusGPS system.
Discard the cranial drill if it has the affected UDI codes listed in the recall notice.
No, the recall states that the drills may not be sterile due to packaging breaches, so they should not be used.
The affected UDI codes are GBY097VA, GBY097RA, GBY097JA, GBY097HA, GBY097GA, and their RB variants.
Check the product label for the model number 3.20mm and the UDI codes listed in the recall notice.
We’ve drafted a message you can send Globus Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0996-2024 — Globus Medical Globus Medical Hello, I own a Globus Medical that is covered by recall Z-0996-2024 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.
