AEQUALIS™ FLEX REVIVE™ · recalls, adverse events, clearances

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.

53 linked reportsInjury 40Malfunction 13

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	0	1.81
2019-02	0	1.74
2019-03	0	1.72
2019-04	0	1.79
2019-05	0	2.02
2019-06	0	1.86
2019-07	0	1.58
2019-08	0	2.14
2019-09	1	1.65
2019-10	4	1.82
2019-11	4	1.7
2019-12	2	1.74
2020-01	0	1.98
2020-02	0	2.11
2020-03	0	1.99
2020-04	0	1.77
2020-05	0	1.65
2020-06	0	1.92
2020-07	0	2.16
2020-08	0	1.79
2020-09	0	1.97
2020-10	1	2.11
2020-11	1	1.88
2020-12	0	1.84
2021-01	0	2.11
2021-02	0	2.02
2021-03	0	2.13
2021-04	0	2.02
2021-05	9	1.96
2021-06	0	1.8
2021-07	0	2.05
2021-08	0	2.2
2021-09	0	1.94
2021-10	0	2.13
2021-11	0	2.1
2021-12	0	2.39
2022-01	0	2.54
2022-02	0	2.33
2022-03	0	2.38
2022-04	0	2.39
2022-05	0	2.1
2022-06	0	2.2
2022-07	3	2.23
2022-08	0	2.2
2022-09	0	2.01
2022-10	0	2.06
2022-11	0	2.07
2022-12	0	2.01
2023-01	0	1.84
2023-02	0	1.96
2023-03	0	2.05
2023-04	1	2.17
2023-05	0	2.1
2023-06	0	2.27
2023-07	0	2.05
2023-08	0	1.7
2023-09	0	1.52
2023-10	1	1.62
2023-11	1	1.63
2023-12	1	1.43
2024-01	0	1.79
2024-02	1	1.78
2024-03	2	1.66
2024-04	1	1.83
2024-05	0	1.64
2024-06	3	1.88
2024-07	1	1.56
2024-08	0	1.71
2024-09	0	1.67
2024-10	1	1.69
2024-11	1	1.58
2024-12	0	1.6
2025-01	0	1.7
2025-02	1	1.6
2025-03	0	1.88
2025-04	2	1.68
2025-05	0	1.74
2025-06	1	1.87
2025-07	6	1.74
2025-08	1	1.58
2025-09	0	1.5
2025-10	2	1.63
2025-11	0	1.75
2025-12	0	2.15
2026-01	0	1.88
2026-02	0	1.83
2026-03	0	1.74
2026-04	0	1.72
2026-05	1	1.72
2026-06	0	1.77

This device (reports/month)Average device in HSD, KWS, PHX (reports/device/month)

Failure-mode summaryAI-generated

40 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-05-07	0001649390-2026-00408	Injury	Available	catalog number
2025-10-15	0001649390-2025-00718	Injury	Available	catalog number
2025-10-15	0001649390-2025-00714	Injury	Available	catalog number
2025-08-01	0001649390-2025-00550	Injury	Available	catalog number
2025-07-30	0001649390-2025-00541	Injury	Available	catalog number
2025-07-21	0001649390-2025-00532	Malfunction	Available	catalog number
2025-07-21	0001649390-2025-00531	Injury	Available	catalog number
2025-07-15	0001649390-2025-00510	Injury	Available	catalog number
2025-07-09	0001649390-2025-00490	Injury	Available	catalog number
2025-06-05	0001649390-2025-00389	Injury	Available	catalog number
2025-04-28	0001649390-2025-00286	Injury	Available	catalog number
2025-04-22	0001649390-2025-00268	Injury	Available	catalog number
2025-02-04	0001649390-2025-00074	Injury	Available	catalog number
2024-11-21	0001649390-2024-00672	Injury	Available	catalog number
2024-10-22	0001649390-2024-00611	Injury	Available	catalog number

Showing the most recent 44 of 53 linked reports.

Showing 1–15 of 44

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2015-07-15	NAI	No action indicated	Tornier, Inc	0
2015-01-22	NAI	No action indicated	Tornier Inc.	0
2014-03-26	NAI	No action indicated	Tornier, Inc	0
2013-01-31	VAI	Voluntary action indicated	Tornier, Inc	4
2011-11-03	NAI	No action indicated	Tornier, Inc	0

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