Arthrex® · 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.

7 linked reportsMalfunction 7

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	3.29
2019-02	0	1.54
2019-03	0	2.14
2019-04	0	2.64
2019-05	0	2.13
2019-06	0	1.92
2019-07	0	2.37
2019-08	0	2
2019-09	0	2.93
2019-10	0	2.52
2019-11	0	2.47
2019-12	0	2.58
2020-01	0	2.52
2020-02	0	2.36
2020-03	0	2.37
2020-04	0	3.32
2020-05	0	2.11
2020-06	0	3
2020-07	0	2.25
2020-08	0	2.77
2020-09	0	2.55
2020-10	0	2.7
2020-11	0	3.5
2020-12	0	3.17
2021-01	0	2.13
2021-02	0	2.89
2021-03	0	2.69
2021-04	0	2.33
2021-05	0	3
2021-06	0	2.88
2021-07	0	2.25
2021-08	0	2.23
2021-09	0	3.66
2021-10	0	2.46
2021-11	0	3.68
2021-12	0	2.86
2022-01	0	3.19
2022-02	0	2.96
2022-03	0	3.06
2022-04	0	2.76
2022-05	0	2.68
2022-06	0	2.39
2022-07	0	2.64
2022-08	0	3.36
2022-09	0	3.29
2022-10	0	4.65
2022-11	0	2.68
2022-12	0	2.88
2023-01	0	4.17
2023-02	0	2.76
2023-03	0	3.71
2023-04	0	3.28
2023-05	0	3.44
2023-06	0	4.76
2023-07	0	2.51
2023-08	0	2.82
2023-09	0	3.67
2023-10	0	2.54
2023-11	0	3.22
2023-12	0	2.94
2024-01	0	3.23
2024-02	0	2.35
2024-03	0	2.94
2024-04	0	2.74
2024-05	0	3.03
2024-06	0	3.81
2024-07	0	3.03
2024-08	0	3.65
2024-09	0	3.19
2024-10	0	3.2
2024-11	2	3.71
2024-12	0	3.54
2025-01	0	4.29
2025-02	0	2.65
2025-03	0	3.03
2025-04	4	3.1
2025-05	0	3.73
2025-06	0	3.45
2025-07	0	3.45
2025-08	0	3.68
2025-09	0	4
2025-10	1	3.5
2025-11	0	3.59
2025-12	0	3.94
2026-01	0	4.03
2026-02	0	4.15
2026-03	0	3.87
2026-04	0	3.43
2026-05	0	6.93
2026-06	0	4.52

This device (reports/month)Average device in JDQ, JDR (reports/device/month)

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-10-01	1220246-2025-04301	Malfunction	Available	catalog number
2025-04-04	1220246-2025-01242	Malfunction	Available	catalog number
2025-04-04	1220246-2025-01241	Malfunction	Available	catalog number
2024-11-08	1220246-2024-08485	Malfunction	Available	catalog number

Showing the most recent 4 of 7 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2025-01-13	VAI	Voluntary action indicated	Arthrex, Inc.	2
2025-01-13	VAI	Voluntary action indicated	Arthrex, Inc.	2
2023-05-05	VAI	Voluntary action indicated	Arthrex, Inc.	2
2023-05-05	VAI	Voluntary action indicated	Arthrex, Inc.	2
2016-08-25	VAI	Voluntary action indicated	Arthrex, Inc.	1
2016-08-25	VAI	Voluntary action indicated	Arthrex, Inc.	1
2013-09-27	NAI	No action indicated	Arthrex Gmbh	0
2013-09-27	NAI	No action indicated	Arthrex Gmbh	0
2013-09-25	NAI	No action indicated	ARTHREX GMBH	0
2013-09-25	NAI	No action indicated	ARTHREX GMBH	0

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