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
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-05-13 | NAI | No action indicated | Biorez, Inc | 0 |
| 2026-04-06 | VAI | Voluntary action indicated | ConMed Corporation | 6 |
| 2026-04-06 | VAI | Voluntary action indicated | ConMed Corporation | 6 |
| 2023-12-14 | NAI | No action indicated | Linvatec Corp. | 0 |
| 2023-08-04 | VAI | Voluntary action indicated | Biorez, Inc | 1 |
| 2022-11-10 | NAI | No action indicated | ConMed Corporation | 0 |
| 2022-11-10 | NAI | No action indicated | ConMed Corporation | 0 |
| 2022-07-13 | NAI | No action indicated | ConMed Corporation | 0 |
| 2022-07-13 | NAI | No action indicated | ConMed Corporation | 0 |
| 2020-09-22 | VAI | Voluntary action indicated | ConMed Corporation | 0 |
| 2020-09-22 | VAI | Voluntary action indicated | ConMed Corporation | 0 |
| 2019-10-17 | NAI | No action indicated | ConMed Corporation | 0 |
| 2019-10-17 | NAI | No action indicated | ConMed Corporation | 0 |
| 2017-02-03 | VAI | Voluntary action indicated | ConMed Corporation | 2 |
| 2017-02-03 | VAI | Voluntary action indicated | ConMed Corporation | 2 |
| 2017-01-23 | NAI | No action indicated | Conmed | 0 |
| 2016-02-03 | VAI | Voluntary action indicated | ConMed Corporation | 5 |
| 2016-02-03 | VAI | Voluntary action indicated | ConMed Corporation | 5 |
| 2014-11-18 | NAI | No action indicated | ConMed Corporation | 0 |
| 2014-11-18 | NAI | No action indicated | ConMed Corporation | 0 |
| 2014-01-29 | WL | Warning Letter | ConMed Corporation | — |
| 2014-01-29 | WL | Warning Letter | ConMed Corporation | — |
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