Avalign Technologies, Inc.
38 recalls · 13 adverse events · 11 inspections · 3 clearances · 1 compliance actions · aggregated across 3 source records
Scorecard
Events per device across the 29,841-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0.000 ▼
3 in the last 12 months
Higher volume than 83% 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
29,841 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| Millennium | 1-70542 | HDF | 00190776387174 | 38 |
| Millennium | 1-70551 | HDF | 00190776303136 | 5 |
| Avalign | VM38-1931 | GEN | 00190776060923 | 3 |
| Millennium | 85-1511023 | HTW | 00190776118211 | 3 |
| Avalign | VM46-9151 | GEI | 00190776005627 | 2 |
| Avalign | VM82-7222 | GZX | 00190776068103 | 2 |
| MILLENNIUM | 0-47130 | GEN | 00190776341381 | 2 |
| Millennium | 72-551410C-PFGT | GEI | 00190776158750 | 2 |
| Millennium | 9560565 | HAE | 00190776114596 | 2 |
| Millennium | Z16113001 | JDW | 00190776135072 | 2 |
| Avalign | L-0130 | HAE | 00190776000547 | 1 |
| Depuy Synthes | 03.028.080 | HTO | 00190776028374 | 1 |
| Depuy Synthes | 03.045.115 | HTO | 00190776152994 | 1 |
| Depuy Synthes | 03.028.060 | HTO | 00190776028336 | 1 |
| MILLENNIUM | 2-4342 | HWM | 00190776323776 | 1 |
| Millennium | 1-1883 | GDJ | 00190776170288 | 1 |
| Millennium | 92-H0499 | HNQ | 00190776202965 | 1 |
| Millennium | 1-74101 | DZN | 00190776411213 | 1 |
| Alphatec Spine | 89000-05-025 | HWT | 00190776148874 | 0 |
| Alphatec Spine | 89000-04-012 | GAD | 00190776148850 | 0 |
| Alphatec Spine | 89000-06-130 | LXH | 00190776148928 | 0 |
| Alphatec Spine | 89000-10-001 | HTF | 00190776148980 | 0 |
| Alphatec Spine | 89000-10-003 | HTF | 00190776149000 | 0 |
| Alphatec Spine | 89000-09-020 | HAE | 00190776148973 | 0 |
| Alphatec Spine | 89000-08-008 | GFI | 00190776148959 | 0 |
| Alphatec Spine | 89000-07-007 | GFI | 00190776148935 | 0 |
| Alphatec Spine | 89000-06-025 | LXH | 00190776148898 | 0 |
| Alphatec Spine | 89000-04-014 | GAD | 00190776148867 | 0 |
| Alphatec Spine | 89000-12 | GEG | 00190776149062 | 0 |
| Alphatec Spine | 89000-08-013 | GFI | 00190776161095 | 0 |
Showing 1–30 of 29,841Next →
Compliance actions
FDA warning letters and enforcement actions (full history).
| Date | Type | Action | Firm |
|---|---|---|---|
| 2014-03-28 | WL | Warning Letter | Instrumed GmbH |
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|---|---|---|---|
| 1000069183 | AVALIGN INTEGRATED MEDICAL SOLUTIONS, INC | Mentor, OH, US | VAI | |
| 3008864603 | AVALIGN TECHNOLOGIES, Inc. | Fort Wayne, IN, US | — | |
| 3007290840 | Instrumed GmbH dba Avalign German Specialty Instruments | TUTTLINGEN Baden-Wurttemberg, DE | NAI | |
| 1421101 | Instrumed International Inc dba Avalign German Specialty Instruments | SCHAUMBURG, IL, US | VAI | |
| 3004215117 | MILLENNIUM SURGICAL CORP | Schaumburg, IL, US | NAI |