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 |
|---|---|---|---|---|
| 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 | 89000-10-003 | HTF | 00190776149000 | 0 |
| Alphatec Spine | 89000-09-020 | HAE | 00190776148973 | 0 |
| Alphatec Spine | 89000-06-025 | LXH | 00190776148898 | 0 |
| Alphatec Spine | 89000-12 | GEG | 00190776149062 | 0 |
| Alphatec Spine | 89000-06-020 | LXH | 00190776161071 | 0 |
| Alphatec Spine | 89000-11-030 | LXH | 00190776149031 | 0 |
| Alphatec Spine | 89000-10-001 | HTF | 00190776148980 | 0 |
| Alphatec Spine | 89000-08-008 | GFI | 00190776148959 | 0 |
| Alphatec Spine | 89000-07-007 | GFI | 00190776148935 | 0 |
| Alphatec Spine | 89000-02-02 | FSM | 00190776161170 | 0 |
| Alphatec Spine | 89000-04-014 | GAD | 00190776148867 | 0 |
| Alphatec Spine | 89000-02-04 | FSM | 00190776161194 | 0 |
| Alphatec Spine | 89000-01-01 | FSM | 00190776161149 | 0 |
| Alphatec Spine | 89000-08-013 | GFI | 00190776161095 | 0 |
| Alphatec Spine | 89000-01 | FSM | 00190776161200 | 0 |
| Alphatec Spine | 89000-02-01 | FSM | 00190776161163 | 0 |
| Alphatec Spine | 89000-01-02 | FSM | 00190776161156 | 0 |
| Alphatec Spine | 89000-11-035 | LXH | 00190776149048 | 0 |
| Alphatec Spine | 89000-10-004 | HTF | 00190776149017 | 0 |
| Alphatec Spine | 89000-08-010 | GFI | 00190776148966 | 0 |
| Alphatec Spine | 89000-08-006 | GFI | 00190776148942 | 0 |
| Alphatec Spine | 89000-11-025 | LXH | 00190776149024 | 0 |
| Avalign | VM91-3517 | HOE | 00190776351496 | 0 |
| Avalign | VM81-2521 | HAE | 00190776117399 | 0 |
| Avalign | VM104-1562 | KAD | 00190776351502 | 0 |
| Avalign | VM91-5462 | HNR | 00190776349899 | 0 |
| Avalign | VM82-50751 | GZX | 00190776352011 | 0 |
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 |