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 |
|---|---|---|---|---|---|---|
| 2015-08-31 | Z-0142-2016 | Class II | Terminated | May contain small amounts of ethylene glycol residueDistribution: Distributed Nationwide and in Germany, Switzerland, and UK. | N/A | clearance family |
| 2015-08-31 | Z-0143-2016 | Class II | Terminated | May contain small amounts of ethylene glycol residueDistribution: Distributed Nationwide and in Germany, Switzerland, and UK. | 12 units | clearance family |
| 2015-08-31 | Z-0148-2016 | Class II | Terminated | May contain small amounts of ethylene glycol residueDistribution: Distributed Nationwide and in Germany, Switzerland, and UK. | 1 unit | clearance family |
Regulatory clearances
Predicate lineage
- K133256
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-01-13 | VAI | Voluntary action indicated | Conformis Inc. | 1 |
| 2023-03-09 | VAI | Voluntary action indicated | Conformis, Inc. | 4 |
| 2021-07-08 | NAI | No action indicated | Conformis Inc. | 0 |
| 2019-12-10 | WL | Warning Letter | Conformis Inc. | — |
| 2019-09-20 | VAI | Voluntary action indicated | Conformis, Inc. | 2 |
| 2019-09-20 | OAI | Official action indicated | Conformis Inc. | 4 |
| 2018-09-07 | VAI | Voluntary action indicated | Conformis, Inc. | 6 |
| 2015-09-14 | VAI | Voluntary action indicated | Conformis Inc. | 3 |
| 2015-06-12 | NAI | No action indicated | Conformis, Inc. | 0 |
| 2013-03-18 | NAI | No action indicated | Conformis, Inc. | 0 |
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