Stock: ZBH. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
1,482
De Novo: 0
PMA approvals
7
278 supplements
Recalled products
3,080
5 class I
Adverse event reports
276K
956 deaths reported
Zimmer Biomet has 3,080 recalled medical device products in 716 recall actions in the records, 5 of them class I (the most serious kind). The newest recall started on Jul 10, 2026. In 2025 it had 36 recalled products.
1,482 510(k) clearances, 0 De Novo grants and 7 original PMA approvals for high-risk devices, plus 278 PMA supplements (changes to approved devices). The newest decision was on Sep 1, 2026.
275,870 reports in total: 956 deaths, 191,991 injuries and 79,332 malfunctions were reported. 20,161 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 | 23 | 0 | 0 | 12 |
| 2025 | 20 | 0 | 0 | 6 |
| 2024 | 25 | 0 | 0 | 10 |
| 2023 |
By product code, all years
All device makers and procedures · ZBH 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 ZBH 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.
| 24 |
| 0 |
| 0 |
| 5 |
| 2022 | 28 | 0 | 0 | 10 |
| 2021 | 29 | 0 | 0 | 6 |
| 2020 | 33 | 0 | 0 | 10 |
| 2019 | 49 | 0 | 0 | 18 |
| 2018 | 18 | 0 | 0 | 18 |
| 2017 | 23 | 0 | 0 | 15 |
| 2016 | 31 | 0 | 0 | 11 |
| 2015 | 58 | 0 | 0 | 15 |
| 2014 | 69 | 0 | 0 | 11 |
| 2013 | 54 | 0 | 0 | 12 |
| 2012 | 53 | 0 | 0 | 11 |
| 2011 | 17 | 0 | 0 | 3 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 17 | 0 | 9,041 | 57 |
| 2025 | 36 | 0 | 20,161 | 36 |
| 2024 | 30 | 0 | 19,381 | 7 |
| 2023 | 31 | 0 | 17,677 | 24 |
| 2022 | 29 | 0 | 15,525 | 22 |
| 2021 | 21 | 0 | 17,757 | 23 |
| 2020 | 233 | 0 | 18,034 | 17 |
| 2019 | 207 | 0 | 19,888 | 31 |
| 2018 | 309 | 2 | 26,123 | 147 |
| 2017 | 326 | 0 | 26,520 | 300 |
| 2016 | 253 | 1 | 15,803 | 86 |
| 2015 | 187 | 1 | 12,541 | 68 |
| 2014 | 149 | 0 | 15,559 | 28 |
| 2013 | 216 | 0 | 11,796 | 12 |
| 2012 | 194 | 1 | 8,086 | 5 |