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.

18 linked reportsInjury 17Malfunction 1

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	0	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	0	2.24
2020-08	0	1.76
2020-09	0	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	0	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	0	2.13
2021-12	0	2.6
2022-01	0	2.65
2022-02	0	2.35
2022-03	0	2.51
2022-04	7	2.48
2022-05	1	2.13
2022-06	0	2.24
2022-07	1	2.2
2022-08	0	2.27
2022-09	0	2.04
2022-10	0	2.12
2022-11	0	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	1	1.76
2023-09	0	1.59
2023-10	0	1.64
2023-11	0	1.69
2023-12	0	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	2	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	1	1.67
2025-01	0	1.74
2025-02	0	1.65
2025-03	0	1.94
2025-04	0	1.73
2025-05	1	1.83
2025-06	0	1.96
2025-07	3	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

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-07-29	3000931034-2025-00393	Injury	Available	exact di
2025-07-15	3000931034-2025-00374	Injury	Available	exact di
2025-07-15	3000931034-2025-00373	Injury	Available	exact di
2025-05-21	3000931034-2025-00263	Injury	Available	exact di
2024-12-30	3000931034-2024-00706	Injury	Available	exact di
2024-06-12	3000931034-2024-00341	Injury	Available	exact di
2024-06-12	3000931034-2024-00340	Injury	Available	exact di
2024-03-07	3000931034-2024-00095	Injury	Available	exact di
2023-08-18	3000931034-2023-00253	Malfunction	Available	exact di
2022-07-21	3000931034-2022-00264	Injury	Available	exact di
2022-05-16	3000931034-2022-00228	Injury	Available	exact di
2022-04-22	3000931034-2022-00207	Injury	Available	exact di
2022-04-14	3000931034-2022-00155	Injury	Available	catalog number
2022-04-14	3000931034-2022-00162	Injury	Available	catalog number

Showing the most recent 14 of 18 linked reports.

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

Similar devices