FDAClass IIFebruary 14, 2024

Globus Medical Cranial Drill with Stop recall

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

Why was Globus Medical Cranial Drill with Stop 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: UDI: GBY097VA (01)00193982302269(17)280313(10)GBY097VA; GBY097RA (01)00193982302269(17)280313(10)GBY097RA; GBY097JA (01)00193982302269(17)280313(10)GBY097JA; GBY097HA (01)00193982302269(17)280313(10)GBY097HA; GBY097GA (01)00193982302269(17)280313(10)GBY097GA; GBY097VA-RB (01)00193982302269(17)280313(10)GBY097VA-RB; GBY097RA-RB (01)00193982302269(17)280313(10)GBY097RA-RB; GBY097JA-RB (01)00193982302269(17)280313(10)GBY097JA-RB; GBY097HA-RB (01)00193982302269(17)280313(10)GBY097HA-RB; GBY097GA-RB (01)00193982302269(17)280313(10)GBY097GA-RB

Product
Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref…
Recalling firm
Globus Medical, Inc.
Distribution
Worldwide - US Nationwide and the countries of Czech Republic, Poland.
Recall date
February 14, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls