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U.S. Department of Health and Human Services

Class 2 Device Recall ExcelsiusGPS

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 Class 2 Device Recall ExcelsiusGPSsee related information
Date Initiated by FirmDecember 15, 2023
Date PostedFebruary 07, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1007-2024
Recall Event ID 93804
510(K)NumberK171651 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
Code Information UDI-DI 00889095998498 Lots FSB136AA FSB121AA FSB241AA FSB207AA FSB136AA FSB121AA FSB110AA FSB073AA FSA286CA FSA286BA FSA286AA FSA263DA FSA263EA FSA263CA FSA263AA FSA263BA FSA160AA FSA160BA FSA105BA FSA105AA FSA053AA FSY319AA FSY279BA FSY279AA FSY272AA FSY230AA FSY098AA FSY098CA FSY098BA FSY048AA FSX093AA FSX205AA FSX141BA FSX141CA FSX141AA FSX093AA FSX063AA FSX041AA FSX041BA FSW142AA FSW094AA
Recalling Firm/
Manufacturer		 Globus Medical, Inc.
2560 General Armistead Ave
Audubon PA 19403-5214
For Additional Information Contact
610-930-1800
Manufacturer Reason
for Recall		Devices may not be rendered sterile due to an internal gap that may be present on some devices causing increased difficulty cleaning prior to steam sterilization. There is an increased risk for infection, inflammation, local toxicity, systemic toxicity, sensitivity, and cross-contamination.
FDA Determined
Cause 2		Device Design
ActionOn December 15, 2023, the firm began to notify customers by phone. On January 9, 2024, firm began following up with letters. Customers were instructed to immediately return affected cannulas to Globus Medical and complete the letter's Response Card. For recall-related questions, please contact Globus Medical Complaint Handling Unit at recall@globusmedical.com. Fax: 610-300-1342.
Quantity in Commerce570
DistributionWorldwide - US Nationwide and the countries of Australia, Austria, Belgium, Czech Republic, Germany, India, Indonesia, Ireland, Italy, Japan, Malaysia, Netherlands, Poland, Saudi Arabia, Singapore, Spain, United Arab Emirates, United Kingdom.
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 = OLO
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