Stock: ATEC. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
130
De Novo: 0
PMA approvals
0
0 supplements
Recalled products
58
0 class I
Adverse event reports
1,854
1 deaths reported
Alphatec has 58 recalled medical device products in 27 recall actions in the records, 0 of them class I (the most serious kind). The newest recall started on May 13, 2026. In 2024 it had 2 recalled products.
130 510(k) clearances, 0 De Novo grants and 0 original PMA approvals for high-risk devices, plus 0 PMA supplements (changes to approved devices). The newest decision was on Jul 14, 2026.
1,854 reports in total: 1 deaths, 632 injuries and 1,206 malfunctions were reported. 295 reports were received in 2025. A report alone does not show that the device caused the problem.
Last 15 years
| Year | 510(k) clearance | De Novo grant | PMA approval | PMA supplement |
|---|---|---|---|---|
| 2026 | 5 | 0 | 0 | 0 |
| 2025 | 5 | 0 | 0 | 0 |
| 2024 | 7 | 0 | 0 | 0 |
| 2023 |
By product code, all years
All device makers and procedures · ATEC stock page
Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to ATEC with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.
| 11 |
| 0 |
| 0 |
| 0 |
| 2022 | 8 | 0 | 0 | 0 |
| 2021 | 6 | 0 | 0 | 0 |
| 2020 | 7 | 0 | 0 | 0 |
| 2019 | 6 | 0 | 0 | 0 |
| 2018 | 7 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 |
| 2016 | 4 | 0 | 0 | 0 |
| 2015 | 3 | 0 | 0 | 0 |
| 2014 | 1 | 0 | 0 | 0 |
| 2013 | 4 | 0 | 0 | 0 |
| 2012 | 2 | 0 | 0 | 0 |
| 2011 | 1 | 0 | 0 | 0 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 3 | 0 | 180 | 1 |
| 2025 | 0 | 0 | 295 | - |
| 2024 | 2 | 0 | 178 | - |
| 2023 | 1 | 0 | 95 | - |
| 2022 | 1 | 0 | 108 | - |
| 2021 | 29 | 0 | 89 | - |
| 2020 | 0 | 0 | 53 | - |
| 2019 | 0 | 0 | 65 | - |
| 2018 | 0 | 0 | 92 | - |
| 2017 | 1 | 0 | 97 | - |
| 2016 | 1 | 0 | 114 | - |
| 2015 | 1 | 0 | 206 | - |
| 2014 | 1 | 0 | 49 | - |
| 2013 | 2 | 0 | 45 | - |
| 2012 | 3 | 0 | 37 | - |