FDA Medical Device Recalls (openFDA)
Globus Medical, Inc.: ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
- Recall number
- Z-1007-2024
- Recalling firm
- Globus Medical, Inc.
- Product
- ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
- Status
- Open, Classified
- Initiated
- 2023-12-15
- Posted
- 2024-02-07
- Terminated
- not on file
- 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 sterilization. There is an increased risk for infection, inflammation, local toxicity, systemic toxicity, sensitivity, and cross-contamination.
- Root cause
- Device Design
- Action
- On 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
- 570
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K171651"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 3004142400
- Firm city
- Audubon
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28