AEQUALIS REVERSED II · 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.

98 linked reportsInjury 88Malfunction 10

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	1.82
2019-02	0	1.85
2019-03	0	1.75
2019-04	2	1.88
2019-05	0	2.1
2019-06	0	1.88
2019-07	0	1.68
2019-08	1	2.18
2019-09	0	1.67
2019-10	0	1.88
2019-11	1	1.72
2019-12	3	1.77
2020-01	2	1.96
2020-02	0	2.08
2020-03	0	2.19
2020-04	0	1.8
2020-05	1	1.66
2020-06	0	1.95
2020-07	3	2.24
2020-08	1	1.76
2020-09	1	1.96
2020-10	1	2.2
2020-11	0	1.9
2020-12	0	1.87
2021-01	0	2.2
2021-02	1	1.99
2021-03	0	2.15
2021-04	2	2.02
2021-05	1	2.02
2021-06	1	1.91
2021-07	1	2.06
2021-08	1	2.19
2021-09	0	1.97
2021-10	0	2.18
2021-11	2	2.13
2021-12	0	2.6
2022-01	0	2.65
2022-02	4	2.35
2022-03	0	2.51
2022-04	0	2.48
2022-05	0	2.13
2022-06	0	2.24
2022-07	0	2.2
2022-08	0	2.27
2022-09	7	2.04
2022-10	0	2.12
2022-11	3	2.16
2022-12	1	2.1
2023-01	1	1.85
2023-02	1	2.06
2023-03	1	2.05
2023-04	4	2.22
2023-05	1	2.12
2023-06	1	2.32
2023-07	1	2.11
2023-08	4	1.76
2023-09	3	1.59
2023-10	0	1.64
2023-11	0	1.69
2023-12	1	1.46
2024-01	0	1.9
2024-02	0	1.89
2024-03	1	1.73
2024-04	0	1.87
2024-05	1	1.72
2024-06	5	1.89
2024-07	1	1.63
2024-08	3	1.73
2024-09	2	1.74
2024-10	0	1.73
2024-11	1	1.64
2024-12	0	1.67
2025-01	0	1.74
2025-02	0	1.65
2025-03	2	1.94
2025-04	2	1.73
2025-05	2	1.83
2025-06	0	1.96
2025-07	2	1.8
2025-08	1	1.61
2025-09	0	1.52
2025-10	1	1.69
2025-11	1	1.74
2025-12	1	2.19
2026-01	4	1.93
2026-02	6	1.85
2026-03	1	1.8
2026-04	1	1.74
2026-05	0	1.8
2026-06	2	1.8

This device (reports/month)Average device in 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
2026-06-15	3000931034-2026-00503	Injury	Available	exact di
2026-06-08	3000931034-2026-00489	Injury	Available	exact di
2026-04-13	3000931034-2026-00342	Injury	Available	exact di
2026-03-03	3000931034-2026-00227	Injury	Available	exact di
2026-02-16	3000931034-2026-00165	Injury	Available	exact di
2026-02-16	3000931034-2026-00173	Injury	Available	exact di
2026-02-16	3000931034-2026-00190	Injury	Available	exact di
2026-02-13	0001649390-2026-00131	Injury	Available	exact di
2026-02-12	3000931034-2026-00144	Injury	Available	exact di
2026-02-12	3000931034-2026-00153	Injury	Available	exact di
2026-01-28	3000931034-2026-00109	Injury	Available	exact di
2026-01-28	3000931034-2026-00105	Injury	Available	exact di
2026-01-06	3000931034-2026-00031	Injury	Available	exact di
2026-01-05	3000931034-2026-00005	Injury	Available	exact di
2025-12-11	3000931034-2025-00672	Injury	Available	exact di

Showing the most recent 92 of 98 linked reports.

Showing 1–15 of 92

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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