Globus Medical Cranial Drill recall
Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S
Why was Globus Medical Cranial Drill 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 Number UDI: GBY094NA (01)00193982302320(17)280311(10)GBY094NA; GBY094MA (01)00193982302320(17)280311(10)GBY094MA; GBY094JA (01)00193982302320(17)280311(10)GBY094JA; GBY094HA (01)00193982302320(17)280311(10)GBY094HA; GBY093XA (01)00193982302320(17)280311(10)GBY093XA; GBY093VA (01)00193982302320(17)280311(10)GBY093VA; GBY094NA-RB (01)00193982302320(17)280311(10)GBY094NA-RB; GBY094MA-RB (01)00193982302320(17)280311(10)GBY094MA-RB; GBY094JA-RB (01)00193982302320(17)280311(10)GBY094JA-RB; GBY094HA-RB (01)00193982302320(17)280311(10)GBY094HA-RB; GBY093XA-RB (01)00193982302320(17)280311(10)GBY093XA-RB; GBY093VA-RB (01)00193982302320(17)280311(10)GBY093VA-RB
- Product
- Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S
- 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)