GLOBUS MEDICAL, INC.
2118 adverse events · 144 clearances · 61 recalls · 54 inspections · 4 compliance actions · aggregated across 4 source records
Scorecard
Events per device across the 44,977-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0.006 ▼
257 in the last 12 months
Higher volume than 86% of companies with 10+ devices
Recalls per device
0 →
0 in the last 12 months
Higher volume than 97% of companies with 10+ devices
These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.
Devices
44,977 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| EXCELSIUS GPS | 6143.1001 | OLO | 00889095481297 | 1082 |
| CREO | 1134.0010 | KWP KWQ MNH MNI NKB OSH | 00889095071139 | 224 |
| CREO | 1119.0010 | KWP KWQ MNH MNI NKB OSH | 00889095059496 | 163 |
| (unnamed) | 685.007 | LXH | 00849044072105 | 39 |
| (unnamed) | 6067.0050 | LXH | 00889095167948 | 29 |
| CREO | 1119.0110 | KWP KWQ MNH MNI NKB OSH | 00889095059656 | 24 |
| CREO | 6120.5000 | LXH | 00889095173604 | 20 |
| FORTIFY | 151.053 | MQP | 00889095042917 | 20 |
| CREO | 5119.1647 | KWP KWQ MNH MNI NKB OSH | 00889095104158 | 19 |
| (unnamed) | 6067.0055 | LXH | 00889095167955 | 17 |
| CREO | 1134.0100 | KWP KWQ MNH MNI NKB OSH | 00889095071146 | 16 |
| CREO | 1067.4645 | KWP KWQ MNH MNI NKB OSH | 00889095023688 | 14 |
| (unnamed) | 6134.0185 | LXH | 00889095178289 | 13 |
| (unnamed) | 6067.0060 | LXH | 00889095167979 | 13 |
| CREO | 5119.1642 | KWP KWQ MNH MNI NKB OSH | 00889095104127 | 10 |
| CREO | 5119.1747 | KWP KWQ MNH MNI NKB OSH | 00889095104721 | 10 |
| EXCELSIUS3D | 6161.1000 | JAA OWB OXO | 00193982184506 | 10 |
| FORTIFY | 151.051 | MQP | 00889095042894 | 10 |
| RESONATE | 1194.3051 | KWQ | 00193982155384 | 10 |
| RESONATE | 1194.3048 | KWQ | 00193982155377 | 10 |
| ALTERA | 1124.1111 | MAX | 00889095069679 | 9 |
| CREO | 1119.0011 | KWP KWQ MNH MNI NKB OSH | 00889095306491 | 9 |
| CREO | 1119.0000 | KWP KWQ MNH MNI NKB OSH | 00889095059489 | 9 |
| (unnamed) | 639.650 | LXH | 00849044075007 | 9 |
| RESONATE | 1194.2030 | KWQ | 00193982154813 | 9 |
| RISE | 193.001 | MAX | 00889095213416 | 9 |
| CREO | 1067.0010 | KWP KWQ MNH MNI NKB OSH | 00889095012958 | 8 |
| CREO | 1067.4745 | KWP KWQ MNH MNI NKB OSH | 00889095023879 | 8 |
| CREO | 5119.6645 | KWP KWQ MNH MNI NKB OSH | 00889095120592 | 8 |
| CREO | 1134.0110 | KWP KWQ MNH MNI NKB OSH | 00889095071153 | 8 |
Showing 1–30 of 44,977Next →
Compliance actions
FDA warning letters and enforcement actions (full history).
| Date | Type | Action | Firm |
|---|---|---|---|
| 2024-07-15 | WL | Warning Letter | Globus Medical, Inc. |
| 2024-07-15 | WL | Warning Letter | Globus Medical, Inc. |
| 2013-09-26 | WL | Warning Letter | Globus Medical, Inc. |
| 2013-09-26 | WL | Warning Letter | Globus Medical, Inc. |
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|---|---|---|---|
| 3011713200 | GLOBUS MEDICAL, INC. | Methuen, MA, US | VAI | |
| 3004142400 | GLOBUS MEDICAL, INC. | AUDUBON, PA, US | VAI | |
| 3030412764 | GLOBUS MEDICAL, INC. | Memphis, TN, US | — | |
| 3008514029 | NEVRO CORP. | Redwood City, CA, US | OAI | |
| 3013491327 | NML Medical, LLC | West Carrollton, OH, US | NAI | |
| 3020969413 | Nevro Medical S.R.L. | El Coyol Alajuela, CR | NAI | |
| 3000779542 | Tissue Transplant Technology, Ltd. d/b/a Bone Bank Allografts | San Antonio, TX, US | — |