Reported Feb 14, 2024 · Ongoing

Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices…

Globus Medical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Globus Medical, Inc. · 2560 General Armistead Ave · Audubon, PA · 19403-5214

Is this the product you have?

  • Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS
  • Ref6143.1842S
Lot codes and dates

10 of 10 products

Products covered by this recall
#BarcodesProduct as published
100193982302269Lot: UDI: GBY097VA (01)00193982302269(17)280313(10)GBY097VA
200193982302269GBY097RA (01)00193982302269(17)280313(10)GBY097RA
300193982302269GBY097JA (01)00193982302269(17)280313(10)GBY097JA
400193982302269GBY097HA (01)00193982302269(17)280313(10)GBY097HA
500193982302269GBY097GA (01)00193982302269(17)280313(10)GBY097GA
600193982302269GBY097VA-RB (01)00193982302269(17)280313(10)GBY097VA-RB
700193982302269GBY097RA-RB (01)00193982302269(17)280313(10)GBY097RA-RB
800193982302269GBY097JA-RB (01)00193982302269(17)280313(10)GBY097JA-RB
900193982302269GBY097HA-RB (01)00193982302269(17)280313(10)GBY097HA-RB
1000193982302269GBY097GA-RB (01)00193982302269(17)280313(10)GBY097GA-RB

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:47 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.