Audubon, PA, United States
Globus Medical, Inc. recalls
5 recalls recorded since 2018, most recently on 3 April 2025. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)4
Terminated or completed1
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 3 April 2025
- Reason
- Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.
- Distribution
- US Nationwide distribution in the state of AR.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1657-2025
- MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Ongoing Class II Medical devices
- Recall started
- 15 December 2023
- 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.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1007-2024
- ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
Ongoing Class II Medical devices
- Recall started
- 11 December 2023
- 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.
- Distribution
- Worldwide - US Nationwide and the countries of Czech Republic, Poland.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0997-2024, Z-0995-2024, Z-0996-2024
- Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S
- Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S
- Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1842S
Ongoing Class I Medical devices
- Recall started
- 7 December 2023
- Reason
- A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement.
- Distribution
- Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0642-2024
- ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Terminated Class II Medical devices
- Recall started
- 22 July 2020
- Terminated
- 19 August 2021
- Reason
- Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
- Distribution
- Worldwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2856-2020, Z-2861-2020, Z-2871-2020, Z-2865-2020, Z-2868-2020, Z-2869-2020, Z-2870-2020, Z-2862-2020, Z-2854-2020, Z-2858-2020, Z-2855-2020, Z-2859-2020 and 10 more
- ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿
- ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿
- ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿
- ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿
- ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿
- ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿
- ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15¿
- ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿
- and 14 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.