Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
- 510(k)K153333Substantially equivalent (SESE) · 2016-01-19clearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-12-19 | WL | Warning Letter | Exactech Sarasota, Inc. | — |
| 2025-08-27 | OAI | Official action indicated | Exactech, Inc. | 9 |
| 2025-08-27 | OAI | Official action indicated | Exactech, Inc. | 9 |
| 2025-07-25 | OAI | Official action indicated | Exactech Sarasota, Inc. | 7 |
| 2024-10-09 | VAI | Voluntary action indicated | Exactech, Inc. | 0 |
| 2024-10-09 | VAI | Voluntary action indicated | Exactech, Inc. | 0 |
| 2024-01-19 | WL | Warning Letter | Exactech, Inc. | — |
| 2024-01-19 | WL | Warning Letter | Exactech, Inc. | — |
| 2023-09-26 | OAI | Official action indicated | Exactech, Inc. | 2 |
| 2023-09-26 | OAI | Official action indicated | Exactech, Inc. | 2 |
| 2021-11-17 | VAI | Voluntary action indicated | Exactech, Inc. | 4 |
| 2021-11-17 | VAI | Voluntary action indicated | Exactech, Inc. | 4 |
| 2020-01-31 | VAI | Voluntary action indicated | Exactech, Inc. | 7 |
| 2020-01-31 | VAI | Voluntary action indicated | Exactech, Inc. | 7 |
| 2017-03-10 | VAI | Voluntary action indicated | Exactech, Inc. | 7 |
| 2017-03-10 | VAI | Voluntary action indicated | Exactech, Inc. | 7 |
| 2015-07-16 | NAI | No action indicated | Exactech, Inc. | 0 |
| 2015-07-16 | NAI | No action indicated | Exactech, Inc. | 0 |
| 2014-08-25 | NAI | No action indicated | Exactech Sarasota, Inc. | 0 |
| 2012-12-11 | NAI | No action indicated | Exactech, Inc. | 0 |
| 2012-12-11 | NAI | No action indicated | Exactech, Inc. | 0 |
| 2010-03-25 | VAI | Voluntary action indicated | Exactech, Inc. | 0 |
| 2010-03-25 | VAI | Voluntary action indicated | Exactech, Inc. | 0 |
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