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.

12 linked reportsInjury 8Malfunction 4

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	2.7
2019-02	0	2.25
2019-03	0	2.48
2019-04	0	2.92
2019-05	0	2.5
2019-06	0	2.25
2019-07	0	2.93
2019-08	0	2.76
2019-09	0	2.73
2019-10	0	2.55
2019-11	0	3.41
2019-12	0	3.71
2020-01	4	3.63
2020-02	0	2.63
2020-03	0	3.53
2020-04	0	3.61
2020-05	0	2.72
2020-06	0	2.81
2020-07	2	3.67
2020-08	0	3.46
2020-09	0	3.19
2020-10	0	3.42
2020-11	0	3.88
2020-12	0	3.64
2021-01	0	3.27
2021-02	0	3.81
2021-03	2	3.82
2021-04	0	4.17
2021-05	0	3.54
2021-06	0	3.19
2021-07	0	3.85
2021-08	0	3.19
2021-09	0	3.8
2021-10	0	3.96
2021-11	0	3.69
2021-12	0	4.07
2022-01	0	4.06
2022-02	0	3.84
2022-03	0	3.39
2022-04	0	2.78
2022-05	0	4.05
2022-06	0	2.99
2022-07	0	3.11
2022-08	0	4.22
2022-09	0	3.75
2022-10	0	4.28
2022-11	0	5.11
2022-12	0	6.48
2023-01	0	5.6
2023-02	0	5.68
2023-03	0	6.57
2023-04	0	5.32
2023-05	0	6.36
2023-06	0	6.96
2023-07	2	6.39
2023-08	0	7.04
2023-09	0	5.22
2023-10	0	6.67
2023-11	0	3.71
2023-12	0	6.06
2024-01	2	4.89
2024-02	0	5.84
2024-03	0	12.62
2024-04	0	17.46
2024-05	0	20.88
2024-06	0	21.68
2024-07	0	19.97
2024-08	0	9.99
2024-09	0	8.5
2024-10	0	6.57
2024-11	0	5.72
2024-12	0	5.3
2025-01	0	4.35
2025-02	0	3.94
2025-03	0	3.8
2025-04	0	4.5
2025-05	0	4.94
2025-06	0	4.44
2025-07	0	3.69
2025-08	0	3.73
2025-09	0	3.5
2025-10	0	4.13
2025-11	0	5.56
2025-12	0	4.55
2026-01	0	4.23
2026-02	0	5.67
2026-03	0	4.25
2026-04	0	4.09
2026-05	0	4.92
2026-06	0	4.6

This device (reports/month)Average device in GAT, HTN, HWC, JDQ (reports/device/month)

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2024-01-30	1220246-2024-00603	Malfunction	Available	catalog number
2023-07-03	1220246-2023-07025	Malfunction	Available	catalog number
2021-03-30	1220246-2021-02798	Injury	Available	catalog number
2020-07-22	1220246-2020-01966	Injury	Available	catalog number
2020-01-27	1220246-2020-01599	Injury	Available	catalog number
2020-01-27	1220246-2020-01598	Injury	Available	catalog number

Showing the most recent 6 of 12 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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