thejoe Globus Medical, Inc.

Globus Medical, Inc.: 29 FDA recall reports

Every medical device recall the FDA has published for Globus Medical, Inc.. The fault, and how the agency graded it.

29Reports

1Class I

6Ongoing

2025-04-30Most recent

1 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	28
Class I	1

By year reported

Year	Reports
2013	1
2020	22
2024	5
2025	1

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;

Z-1657-2025 · Class II · reported 2025-04-30 · Ongoing

Why it was recalled: 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.
Product: MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Where it went: US Nationwide distribution in the state of AR.
How much: 1 unit

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

Z-1007-2024 · Class II · reported 2024-02-14 · Ongoing

Why it was recalled: 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.
Product: ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
Where it went: 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.
How much: 570

Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices w

Z-0997-2024 · Class II · reported 2024-02-14 · Ongoing

Why it was recalled: Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
Product: Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S
Where it went: Worldwide - US Nationwide and the countries of Czech Republic, Poland.

Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial

Z-0995-2024 · Class II · reported 2024-02-14 · Ongoing

Why it was recalled: Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
Product: Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S
Where it went: Worldwide - US Nationwide and the countries of Czech Republic, Poland.

Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of crania

Z-0996-2024 · Class II · reported 2024-02-14 · Ongoing

Why it was recalled: Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
Product: Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1842S
Where it went: Worldwide - US Nationwide and the countries of Czech Republic, Poland.

Class I

ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100

Z-0642-2024 · Class I · reported 2024-01-24 · Ongoing

Why it was recalled: 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.
Product: ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Where it went: Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.
How much: 9

ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿

Z-2856-2020 · Class II · reported 2020-09-02 · Terminated

Why it was recalled: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Product: ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿
Where it went: Worldwide Distribution
How much: N/A

ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿

Z-2861-2020 · Class II · reported 2020-09-02 · Terminated

Why it was recalled: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Product: ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿
Where it went: Worldwide Distribution
How much: N/A

ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿

Z-2871-2020 · Class II · reported 2020-09-02 · Terminated

Why it was recalled: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Product: ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿
Where it went: Worldwide Distribution
How much: N/A

ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿

Z-2865-2020 · Class II · reported 2020-09-02 · Terminated

Why it was recalled: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Product: ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿
Where it went: Worldwide Distribution
How much: N/A

ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿

Z-2868-2020 · Class II · reported 2020-09-02 · Terminated

Why it was recalled: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Product: ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿
Where it went: Worldwide Distribution
How much: N/A

ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿

Z-2869-2020 · Class II · reported 2020-09-02 · Terminated

Why it was recalled: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Product: ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿
Where it went: Worldwide Distribution
How much: N/A

ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15¿

Z-2870-2020 · Class II · reported 2020-09-02 · Terminated

Why it was recalled: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Product: ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15¿
Where it went: Worldwide Distribution
How much: N/A

ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿

Z-2862-2020 · Class II · reported 2020-09-02 · Terminated

Why it was recalled: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Product: ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿
Where it went: Worldwide Distribution
How much: N/A

ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿

Z-2854-2020 · Class II · reported 2020-09-02 · Terminated

Why it was recalled: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Product: ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿
Where it went: Worldwide Distribution
How much: N/A

ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿

Z-2858-2020 · Class II · reported 2020-09-02 · Terminated

Why it was recalled: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Product: ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿
Where it went: Worldwide Distribution
How much: N/A

ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿

Z-2855-2020 · Class II · reported 2020-09-02 · Terminated

Why it was recalled: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Product: ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿
Where it went: Worldwide Distribution
How much: N/A

ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿

Z-2859-2020 · Class II · reported 2020-09-02 · Terminated

Why it was recalled: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Product: ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿
Where it went: Worldwide Distribution
How much: N/A

ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile)

Z-2850-2020 · Class II · reported 2020-09-02 · Terminated

Why it was recalled: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Product: ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile)
Where it went: Worldwide Distribution
How much: N/A

ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8¿

Z-2866-2020 · Class II · reported 2020-09-02 · Terminated

Why it was recalled: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Product: ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8¿
Where it went: Worldwide Distribution
How much: N/A

ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8¿

Z-2860-2020 · Class II · reported 2020-09-02 · Terminated

Why it was recalled: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Product: ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8¿
Where it went: Worldwide Distribution
How much: N/A

ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8¿

Z-2867-2020 · Class II · reported 2020-09-02 · Terminated

Why it was recalled: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Product: ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8¿
Where it went: Worldwide Distribution
How much: N/A

ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿

Z-2852-2020 · Class II · reported 2020-09-02 · Terminated

Why it was recalled: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Product: ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿
Where it went: Worldwide Distribution
How much: N/A

ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿

Z-2853-2020 · Class II · reported 2020-09-02 · Terminated

Why it was recalled: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Product: ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿
Where it went: Worldwide Distribution
How much: N/A

ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿

Z-2863-2020 · Class II · reported 2020-09-02 · Terminated

Why it was recalled: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Product: ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿
Where it went: Worldwide Distribution
How much: N/A

ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15¿

Z-2864-2020 · Class II · reported 2020-09-02 · Terminated

Why it was recalled: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Product: ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15¿
Where it went: Worldwide Distribution
How much: N/A

ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿

Z-2851-2020 · Class II · reported 2020-09-02 · Terminated

Why it was recalled: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Product: ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿
Where it went: Worldwide Distribution
How much: N/A

ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿

Z-2857-2020 · Class II · reported 2020-09-02 · Terminated

Why it was recalled: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Product: ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿
Where it went: Worldwide Distribution
How much: N/A

Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated onl

Z-0123-2014 · Class II · reported 2013-11-06 · Terminated

Why it was recalled: The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.
Product: Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse Bone Void Filleris a bone graft extender to be used with autogenous bone marrow aspirate or autograft
Where it went: USA Nationwide Distribution.
How much: 193

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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