Stock: OFIX. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
204
De Novo: 0
PMA approvals
3
61 supplements
Recalled products
112
0 class I
Adverse event reports
2,618
3 deaths reported
Orthofix has 112 recalled medical device products in 42 recall actions in the records, 0 of them class I (the most serious kind). The newest recall started on Aug 19, 2026. In 2025 it had 11 recalled products.
204 510(k) clearances, 0 De Novo grants and 3 original PMA approvals for high-risk devices, plus 61 PMA supplements (changes to approved devices). The newest decision was on Jul 1, 2026.
2,618 reports in total: 3 deaths, 1,170 injuries and 1,393 malfunctions were reported. 171 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 | 3 | 0 | 0 | 0 |
| 2025 | 4 | 0 | 0 | 1 |
| 2024 | 13 | 0 | 0 | 1 |
| 2023 |
By product code, all years
All device makers and procedures · OFIX 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 OFIX 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.
| 7 |
| 0 |
| 0 |
| 0 |
| 2022 | 8 | 0 | 1 | 2 |
| 2021 | 17 | 0 | 0 | 0 |
| 2020 | 24 | 0 | 0 | 1 |
| 2019 | 9 | 0 | 0 | 5 |
| 2018 | 16 | 0 | 0 | 6 |
| 2017 | 17 | 0 | 0 | 3 |
| 2016 | 12 | 0 | 0 | 2 |
| 2015 | 8 | 0 | 0 | 2 |
| 2014 | 11 | 0 | 0 | 2 |
| 2013 | 6 | 0 | 0 | 0 |
| 2012 | 8 | 0 | 0 | 0 |
| 2011 | 1 | 0 | 0 | 2 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 6 | 0 | 133 | - |
| 2025 | 11 | 0 | 171 | - |
| 2024 | 8 | 0 | 208 | - |
| 2023 | 0 | 0 | 91 | - |
| 2022 | 0 | 0 | 86 | - |
| 2021 | 0 | 0 | 151 | - |
| 2020 | 0 | 0 | 164 | 1 |
| 2019 | 0 | 0 | 136 | - |
| 2018 | 54 | 0 | 182 | - |
| 2017 | 2 | 0 | 123 | - |
| 2016 | 2 | 0 | 149 | - |
| 2015 | 2 | 0 | 148 | - |
| 2014 | 1 | 0 | 125 | 2 |
| 2013 | 3 | 0 | 156 | - |
| 2012 | 2 | 0 | 164 | - |