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
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2026-02-20 | Z-1821-2026 | Class II | Open, Classified | Due to a quality issue regarding the presence of burr on the finished cervical plate product.Distribution: U.S. Nationwide distribution in the states of CA, IL, NY and TX. | 511 | code info di |
Regulatory clearances
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2019-06-04 | VAI | Voluntary action indicated | Clariance Inc | 6 |
| 2014-06-30 | NAI | No action indicated | Clariance Inc | 0 |
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