FDA recall Z-1007-2024

Globus Medical, Inc. · Class II · device

Product

ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844

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.

Key facts

Status
Ongoing
Initiation date
2023-12-15
Report date
2024-02-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Audubon, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1007-2024