ACTIS · 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.

43 linked reportsMalfunction 43

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	2.16
2019-02	0	1.22
2019-03	0	1.65
2019-04	0	2
2019-05	0	1.94
2019-06	0	1.5
2019-07	0	1.83
2019-08	1	1.5
2019-09	3	2.24
2019-10	0	4.32
2019-11	1	2.15
2019-12	0	2.25
2020-01	1	2
2020-02	0	1.89
2020-03	1	2.33
2020-04	0	2.29
2020-05	0	1.46
2020-06	1	2
2020-07	0	1.81
2020-08	2	2.33
2020-09	0	1.73
2020-10	0	1.91
2020-11	0	1.57
2020-12	0	2.19
2021-01	1	1.53
2021-02	1	1.64
2021-03	0	1.83
2021-04	4	3.46
2021-05	1	1.43
2021-06	0	1.5
2021-07	0	1.56
2021-08	0	3.23
2021-09	1	2.06
2021-10	0	1.85
2021-11	0	1.86
2021-12	0	1.7
2022-01	0	1.87
2022-02	0	2.23
2022-03	0	2.46
2022-04	0	1.56
2022-05	0	2
2022-06	0	1.88
2022-07	0	3.71
2022-08	1	1.87
2022-09	0	1.7
2022-10	0	2
2022-11	1	2.14
2022-12	0	2.86
2023-01	0	2.81
2023-02	2	2.07
2023-03	1	1.62
2023-04	0	2.11
2023-05	1	1.48
2023-06	0	1.82
2023-07	1	2.13
2023-08	4	2.54
2023-09	2	1.92
2023-10	0	3.36
2023-11	1	2.05
2023-12	0	2.09
2024-01	2	2.33
2024-02	1	3.43
2024-03	0	1.69
2024-04	0	1.82
2024-05	2	1.7
2024-06	0	2.67
2024-07	0	1.33
2024-08	0	1.41
2024-09	0	1.5
2024-10	0	1.97
2024-11	0	2.17
2024-12	0	1.62
2025-01	0	1.82
2025-02	0	1.22
2025-03	0	1.42
2025-04	0	1.47
2025-05	1	3.38
2025-06	0	2.21
2025-07	1	2.23
2025-08	0	1.54
2025-09	0	1
2025-10	0	2.07
2025-11	0	1
2025-12	0	1.4
2026-01	0	3.64
2026-02	1	1.22
2026-03	0	9.44
2026-04	1	1.36
2026-05	2	1.8
2026-06	0	1.36

This device (reports/month)Average device in HTQ (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
2026-05-13	1818910-2026-08761	Malfunction	Available	exact di
2026-05-05	1818910-2026-08271	Malfunction	Available	exact di
2026-04-01	1818910-2026-05629	Malfunction	Available	exact di
2026-02-17	1818910-2026-03043	Malfunction	Available	exact di
2025-07-18	1818910-2025-12423	Malfunction	Available	exact di
2025-05-27	1818910-2025-08548	Malfunction	Available	exact di
2024-05-15	1818910-2024-10668	Malfunction	Available	exact di
2024-05-15	1818910-2024-10667	Malfunction	Available	exact di
2024-02-16	1818910-2024-03501	Malfunction	Available	exact di
2024-01-24	1818910-2024-01682	Malfunction	Available	exact di
2024-01-03	1818910-2024-00185	Malfunction	Available	exact di
2023-11-28	1818910-2023-24148	Malfunction	Available	exact di
2023-09-29	1818910-2023-19808	Malfunction	Available	exact di
2023-09-19	1818910-2023-19091	Malfunction	Available	exact di
2023-08-22	1818910-2023-17181	Malfunction	Available	exact di

Showing 1–15 of 43

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2024-07-04	NAI	No action indicated	DEPUY (IRELAND)	0
2015-01-08	NAI	No action indicated	DEPUY (IRELAND)	0
2012-01-26	VAI	Voluntary action indicated	DEPUY (IRELAND)	1
2011-02-03	NAI	No action indicated	DEPUY (IRELAND)	0

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