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.

2 linked reportsMalfunction 2

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	1.36
2019-02	0	1.42
2019-03	0	1.37
2019-04	0	1.5
2019-05	0	1.41
2019-06	0	1.39
2019-07	0	1.48
2019-08	0	1.35
2019-09	0	1.39
2019-10	0	1.35
2019-11	0	1.35
2019-12	0	1.46
2020-01	0	1.36
2020-02	0	1.34
2020-03	0	1.65
2020-04	0	1.26
2020-05	0	1.09
2020-06	0	1.77
2020-07	0	1.78
2020-08	0	1.84
2020-09	0	1.46
2020-10	0	1.35
2020-11	0	1.76
2020-12	0	1.44
2021-01	0	1.45
2021-02	0	1.56
2021-03	0	1.6
2021-04	0	1.56
2021-05	0	1.43
2021-06	0	1.63
2021-07	0	1.54
2021-08	0	1.49
2021-09	0	1.55
2021-10	0	1.53
2021-11	0	1.43
2021-12	0	1.62
2022-01	0	1.32
2022-02	0	1.63
2022-03	0	1.45
2022-04	0	1.46
2022-05	0	1.57
2022-06	0	1.53
2022-07	0	1.45
2022-08	0	1.46
2022-09	0	2.2
2022-10	0	1.45
2022-11	0	1.46
2022-12	0	1.38
2023-01	0	1.43
2023-02	0	1.43
2023-03	0	1.54
2023-04	0	1.51
2023-05	0	1.67
2023-06	0	1.75
2023-07	0	1.4
2023-08	0	1.33
2023-09	0	1.16
2023-10	0	1.25
2023-11	0	1.49
2023-12	0	1.22
2024-01	0	1.31
2024-02	0	1.24
2024-03	0	1.4
2024-04	0	1.36
2024-05	2	1.27
2024-06	0	1.29
2024-07	0	1.22
2024-08	0	1.33
2024-09	0	1.32
2024-10	0	1.4
2024-11	0	1.23
2024-12	0	1.31
2025-01	0	1.35
2025-02	0	1.3
2025-03	0	1.19
2025-04	0	1.3
2025-05	0	1.33
2025-06	0	1.34
2025-07	0	1.39
2025-08	0	1.39
2025-09	0	1.22
2025-10	0	1.32
2025-11	0	1.36
2025-12	0	1.39
2026-01	0	1.35
2026-02	0	1.33
2026-03	0	1.41
2026-04	0	1.3
2026-05	0	1.34
2026-06	0	1.31

This device (reports/month)Average device in HSX, KRR, MBH (reports/device/month)

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2024-05-09	1220246-2024-03002	Malfunction	Available	catalog number

Showing the most recent 1 of 2 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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