ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
Summary
The FDA issued a Class II for ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No by Globus Medical, Inc.. Reason: 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 st.
Details
Source
Device Recall
External ID
Z-1007-2024
Action Date
2024-02-14
Status
Ongoing
Category
device
Product Description
ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
Lot/Code Info: 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
Quantity Affected: 570
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.
Distribution
Worldwide - 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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-15
Company
Audubon, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 274 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Globus Medical, Inc. has 40 FDA actions in our database, including 6 recalls and 34 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Globus Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Globus Medical, Inc. have FDA actions?
Globus Medical, Inc. has 40 FDA actions in our database, including 6 recalls and 34 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1007-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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