Recall Z-1007-2024— Globus Medical, Inc.

Name: FDA recall Z-1007-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-15

Class II · Ongoing

Class II FDA medical device recall by Globus Medical, Inc., initiated 2023-12-15. It names one FDA 510(k) clearance: K171651. Product: ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844. 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..

Recalling firm: Globus Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-12-15
Firm location: Audubon, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K171651 — EXCELSIUS GPSGlobus Medical, Inc.·cleared 2017-08-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.