AEQUALIS REVERSED · 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.

24 linked reportsInjury 24

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

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-07-01	3000931034-2025-00335	Injury	Available	exact di
2025-07-01	3000931034-2025-00334	Injury	Available	exact di
2024-03-14	3000931034-2024-00103	Injury	Available	exact di
2023-12-29	3000931034-2023-00486	Injury	Available	exact di
2022-11-17	0001649390-2022-00103	Injury	Available	catalog number
2022-11-17	0001649390-2022-00100	Injury	Available	catalog number
2022-07-21	0001649390-2022-00040	Injury	Available	catalog number
2021-11-23	3000931034-2021-00347	Injury	Available	exact di
2021-11-23	3000931034-2021-00348	Injury	Available	exact di
2021-11-10	3000931034-2021-00336	Injury	Available	exact di
2021-04-22	3000931034-2021-00043	Injury	Available	exact di
2020-09-01	3000931034-2020-00113	Injury	Available	exact di
2020-09-01	3000931034-2020-00132	Injury	Available	exact di
2020-07-07	3000931034-2020-00080	Injury	Available	exact di
2020-07-07	3000931034-2020-00075	Injury	Available	exact di

Showing the most recent 18 of 24 linked reports.

Showing 1–15 of 18

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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