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.

32 linked reportsInjury 28Malfunction 4

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	0	1.65
2019-10	3	1.82
2019-11	0	1.7
2019-12	1	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	0	2.11
2020-11	0	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	0	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	0	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	0	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	0	1.62
2023-11	0	1.63
2023-12	1	1.43
2024-01	0	1.79
2024-02	1	1.78
2024-03	0	1.66
2024-04	0	1.83
2024-05	0	1.64
2024-06	2	1.88
2024-07	0	1.56
2024-08	0	1.71
2024-09	0	1.67
2024-10	1	1.69
2024-11	0	1.58
2024-12	0	1.6
2025-01	0	1.7
2025-02	2	1.6
2025-03	1	1.88
2025-04	1	1.68
2025-05	1	1.74
2025-06	2	1.87
2025-07	2	1.74
2025-08	0	1.58
2025-09	2	1.5
2025-10	0	1.63
2025-11	1	1.75
2025-12	1	2.15
2026-01	4	1.88
2026-02	3	1.83
2026-03	0	1.74
2026-04	1	1.72
2026-05	0	1.72
2026-06	2	1.77

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-06-16	0001649390-2026-00556	Injury	Available	catalog number
2026-06-16	0001649390-2026-00558	Injury	Available	catalog number
2026-04-29	0001649390-2026-00384	Injury	Available	catalog number
2026-02-23	0001649390-2026-00187	Injury	Available	catalog number
2026-02-16	0001649390-2026-00149	Injury	Available	catalog number
2026-01-28	0001649390-2026-00078	Injury	Available	catalog number
2026-01-28	0001649390-2026-00076	Injury	Available	catalog number
2025-12-01	0001649390-2025-00911	Injury	Available	catalog number
2025-11-13	0001649390-2025-00820	Injury	Available	catalog number
2025-09-22	0001649390-2025-00669	Injury	Available	catalog number
2025-09-08	0001649390-2025-00631	Injury	Available	catalog number
2025-07-30	0001649390-2025-00539	Injury	Available	catalog number
2025-07-15	0001649390-2025-00509	Injury	Available	exact di
2025-06-05	0001649390-2025-00387	Injury	Available	catalog number
2025-05-20	0001649390-2025-00333	Injury	Available	catalog number

Showing the most recent 28 of 32 linked reports.

Showing 1–15 of 28

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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