ALTERARecalls & reported problems across all models

Globus Medical, Inc. · 23 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 13
Deaths reported: 0
Injuries reported: 2
Recalls: 21

We found 23 models of ALTERA by Globus Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 13 adverse event reports in the FDA's MAUDE database, received between Jul 7, 2021 and May 8, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

21 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

Last 36 months. The most recent month may be incomplete.

ALTERA recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

Jul 22, 2020Terminated
Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2871-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Jul 22, 2020Terminated
Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2870-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Jul 22, 2020Terminated
Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2869-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Jul 22, 2020Terminated
Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2868-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Jul 22, 2020Terminated
Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2867-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Jul 22, 2020Terminated
Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2866-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Jul 22, 2020Terminated
Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2865-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Jul 22, 2020Terminated
Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2864-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Jul 22, 2020Terminated
Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2863-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Jul 22, 2020Terminated
Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2862-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Jul 22, 2020Terminated
Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2861-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Jul 22, 2020Terminated
Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2860-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Jul 22, 2020Terminated
Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2859-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Jul 22, 2020Terminated
Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2858-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Jul 22, 2020Terminated
Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2857-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Jul 22, 2020Terminated
Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2856-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Jul 22, 2020Terminated
Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2855-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Jul 22, 2020Terminated
Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2854-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Jul 22, 2020Terminated
Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2853-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Jul 22, 2020Terminated
Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2852-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Jul 22, 2020Terminated
Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Z-2851-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported ALTERA problems

Device problems

Break1
Collapse1
Detachment of Device or Device Component1
Device Slipped1
Difficult to Insert1
Dull, Blunt1
Fracture1
Insufficient Device Problem Information1

Patient problems

Insufficient Information3
Failure of Implant2
Laceration(s)2
No Clinical Signs, Symptoms or Conditions2
Cerebrospinal Fluid Leakage1
Foreign Body In Patient1
Hemorrhage/Blood Loss/Bleeding1
Nervous System Injury1

ALTERA models

23 models, most reported first. Each model has its own page with its reports, recalls and device details.

ALTERA 1124.1111
Intervertebral fusion device with bone graft, lumbar
1 recall4 reports
ALTERA 1124.1011
Intervertebral fusion device with bone graft, lumbar
1 recall2 reports
ALTERA 1124.1112
Intervertebral fusion device with bone graft, lumbar
1 recall1 report
ALTERA 1124.1013
Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1015
Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1032
Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1033
Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1035
Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1113
Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1115
Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1132
Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1133
Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1135
Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1211
Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1212
Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1213
Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1215
Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1232
Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1233
Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1235
Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 1124.1012
Intervertebral fusion device with bone graft, lumbar
1 recall0 reports
ALTERA 6124.0002
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
3 reports
ALTERA 6124.0003
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
3 reports

Recent ALTERA adverse event reports

The 13 most recent reports across all models, in the reporter's own words as published by the FDA.

MalfunctionMay 8, 2026Migration
IT WAS REPORTED THAT AN ALTERA WAS INSERTED AT L5/S AND FIXED POSTERIORLY WITH COMPETITOR'S SCREW SYSTEM. THEN ON (B)(6) 2026 THE ALTERA WAS INSERTED AT L4/L5 DUE TO ADJACENT SEGMENT DISEASE. THEN ON (B)(6) 2026, DUE TO BACK OUT OF ALTERA INSERTED AT L4/5, IT WAS REMOVED FROM L4/5 AND A DIFFERENT CAGE WAS INSERTED INSTEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25122784 ↗
MalfunctionFeb 3, 2026Collapse
IT WAS REPORTED THAT AFTER THE ORIGINAL CASE ON (B)(6) 2024 THE SURGEON NOTICED THE ALTERA CAGE HAS COLLAPSED ON A FOLLOW UP ON (B)(6) 2025. THE IMPLANT REMAINS IN THE PATIENT. THIS EVENT OCCURRED IN THE UK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24251343 ↗
MalfunctionNov 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT WHILE TRYING TO EXPAND AN ALTERA CAGE INSIDE A PATIENT, THE TIP OF THE DRIVER BROKE OFF INSIDE THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 20698600 ↗
MalfunctionApr 15, 2024Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT DURING A SURGERY THE SPACER WAS NOT ABLE TO EXPAND, BUT WAS LEFT IN THE PATIENT POST OPERATIVELY. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Spinal Column Injury
MAUDE report 19104493 ↗
MalfunctionMar 5, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING A SURGERY, WHILE THE SPACER WAS BEING REMOVED, THE DURA MATER WAS INJURED. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Nervous System Injury
MAUDE report 18838132 ↗
MalfunctionMar 5, 2024Fracture; Fracture
IT WAS REPORTED THAT A FRACTURE OF L4 VERTEBRAL BODY WAS FOUND 1 WEEK POST OPERATIVELY. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Insufficient Information
MAUDE report 18837380 ↗
MalfunctionMar 5, 2024Product Quality Problem; Product Quality Problem
IT WAS REPORTED THERE WAS AN ISSUE REMOVING AN ALTERA SPACER DURING SURGERY, AND IT WAS LEFT IN THE PATIENT POST OPERATIVELY. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Failure of Implant
MAUDE report 18837330 ↗
MalfunctionFeb 29, 2024Dull, Blunt; Dull, Blunt
IT WAS REPORTED THAT AN ALTERA SPACER WAS LEFT IN THE PATIENT POST OPERATIVELY AFTER IT DID NOT EXPAND. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Failure of Implant
MAUDE report 18811048 ↗
MalfunctionFeb 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DISTAL TIP OF THE INSTRUMENT BROKE OFF IN THE IMPLANT DURING EXPANSION AND WAS UNABLE TO BE RETRIEVED.
Patient problems: Insufficient Information
MAUDE report 18810689 ↗
MalfunctionSep 9, 2022Difficult to Insert; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING A PROCEDURE TO INSERT AN ALTERA CAGE MET RESISTANCE AND THEN A DURAL TEAR WAS OBSERVED AND FIXED INTRAOPERATIVELY. THERE ARE NO KNOWN SIDE EFFECTS AFTER SURGERY.
Patient problems: Laceration(s)
MAUDE report 15392015 ↗
InjuryMay 25, 2022Use of Device Problem
IT WAS REPORTED THAT DURING SURGERY A VEIN WAS PUNCTURED CAUSING THE PATIENT SIGNIFICANT BLOOD LOSS.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)
MAUDE report 14498442 ↗
MalfunctionFeb 8, 2022Break
IT WAS REPORTED THAT THE TIP OF (1) ALTERA THREADED ROD BROKE OFF INTO THE CAGE DURING IMPLANTATION. THE CAGE WITH THE BROKEN TIP WAS LEFT IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 13486148 ↗
InjuryJul 7, 2021Device Slipped
IT WAS REPORTED BY A REPRESENTATIVE FROM THE (B)(6) THAT WHILE IMPACTING A LOADED ALTERA INSERTER WITH A MALLET, THE IMPLANT SLIPPED, PUSHING THE TIP OF THE INSERTER FORK OFF THE CAGE AND PUNCTURED THE RIGHT SIDE OF THE PATIENT'S DURA, CAUSING A DURAL LEAK.
Patient problems: Cerebrospinal Fluid Leakage; Perforation
MAUDE report 12131694 ↗

Other Globus Medical, Inc. products

All Globus Medical, Inc. devices →

Sources and updates

Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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