AEQUALIS · 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.

6 linked reportsInjury 6

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	1.68
2019-02	0	1.59
2019-03	0	1.68
2019-04	0	1.52
2019-05	0	1.76
2019-06	0	1.87
2019-07	0	1.41
2019-08	0	1.97
2019-09	0	1.48
2019-10	0	1.8
2019-11	0	1.62
2019-12	0	1.74
2020-01	0	1.89
2020-02	0	2.15
2020-03	0	1.76
2020-04	0	1.72
2020-05	0	1.43
2020-06	0	1.8
2020-07	0	1.91
2020-08	0	1.63
2020-09	0	1.92
2020-10	0	2.1
2020-11	0	1.85
2020-12	0	1.82
2021-01	1	1.95
2021-02	0	1.82
2021-03	0	1.98
2021-04	0	1.76
2021-05	0	1.76
2021-06	0	1.63
2021-07	0	1.87
2021-08	0	2.03
2021-09	0	1.66
2021-10	0	1.71
2021-11	0	1.97
2021-12	0	1.93
2022-01	0	2.04
2022-02	0	2.04
2022-03	0	1.73
2022-04	0	2.04
2022-05	0	1.88
2022-06	0	2.01
2022-07	0	2.05
2022-08	0	2
2022-09	0	1.84
2022-10	0	1.87
2022-11	0	2.02
2022-12	0	1.82
2023-01	0	1.72
2023-02	0	1.94
2023-03	0	1.93
2023-04	1	1.92
2023-05	0	2
2023-06	0	2.26
2023-07	0	2.07
2023-08	0	1.67
2023-09	0	1.51
2023-10	0	1.56
2023-11	0	1.61
2023-12	0	1.41
2024-01	0	1.99
2024-02	0	1.76
2024-03	0	1.68
2024-04	0	1.77
2024-05	0	1.72
2024-06	0	1.9
2024-07	0	1.6
2024-08	0	1.7
2024-09	0	1.71
2024-10	0	1.61
2024-11	0	1.58
2024-12	0	1.63
2025-01	0	1.72
2025-02	0	1.56
2025-03	0	1.84
2025-04	0	1.63
2025-05	1	1.75
2025-06	0	1.83
2025-07	0	1.71
2025-08	0	1.53
2025-09	0	1.51
2025-10	0	1.62
2025-11	1	1.71
2025-12	1	2.11
2026-01	0	1.87
2026-02	0	1.8
2026-03	1	1.75
2026-04	0	1.7
2026-05	0	1.75
2026-06	0	1.68

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-03-10	3000931034-2026-00251	Injury	Available	exact di
2025-12-24	3000931034-2025-00697	Injury	Available	exact di
2025-11-05	3000931034-2025-00593	Injury	Available	exact di
2025-05-21	3000931034-2025-00269	Injury	Available	exact di
2023-04-20	3000931034-2023-00109	Injury	Available	exact di
2021-01-12	3000931034-2021-00005	Injury	Available	exact di

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