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U.S. Department of Health and Human Services

Class 2 Device Recall Globus Medical Cranial Drill with Stop, 3.20mm

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 Class 2 Device Recall Globus Medical Cranial Drill with Stop, 3.20mmsee related information
Date Initiated by FirmDecember 11, 2023
Date PostedFebruary 06, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0996-2024
Recall Event ID 93742
510(K)NumberK200047 
Product Classification Neurological stereotaxic Instrument - Product Code HAW
ProductGlobus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1842S
Code Information 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
Recalling Firm/
Manufacturer		 Globus Medical, Inc.
2560 General Armistead Ave
Audubon PA 19403-5214
For Additional Information ContactSAME
610-930-1800
Manufacturer Reason
for Recall		Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
FDA Determined
Cause 2		Package design/selection
ActionGlobus Medical issued Urgent Medical Device Recall Notification letter on 12/11/23. Letter states reason for recall, health risk and action to take: Customers are instructed to immediately return all affected sterile-packed Cranial Drills to Globus Medical and complete the attached Response Card. Report any adverse events believed to be associated with the affected sterile-packed Cranial Drills to Globus Medical immediately. For Questions and Support: Globus Medical Contact Contact Information Areas of Support Globus Medical Complaint Handling Unit Fax: 610-300-1342 Email: recall@globusmedical.com Recall Related Questions
DistributionWorldwide - US Nationwide and the countries of Czech Republic, Poland.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HAW
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