Recall Z-0997-2024— Globus Medical, Inc.

Name: FDA recall Z-0997-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-11

Class II · Ongoing

Class II FDA medical device recall by Globus Medical, Inc., initiated 2023-12-11. It names one FDA 510(k) clearance: K200047. Product: Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S. Reason: Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip..

Recalling firm: Globus Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-12-11
Firm location: Audubon, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K200047 — ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.·cleared 2020-07-10

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

Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S

Reason for recall

Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.

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