Depuy Synthes · 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.

1 linked reportMalfunction 1

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	1	1.89
2019-02	0	1.38
2019-03	0	1.4
2019-04	0	1.43
2019-05	0	3
2019-06	0	3.23
2019-07	0	1.94
2019-08	0	4.47
2019-09	0	3.44
2019-10	0	3.31
2019-11	0	3.76
2019-12	0	4.07
2020-01	0	3.07
2020-02	0	3.11
2020-03	0	1.81
2020-04	0	1.35
2020-05	0	3.36
2020-06	0	1.4
2020-07	0	1.68
2020-08	0	2.89
2020-09	0	2.24
2020-10	0	2.91
2020-11	0	4.03
2020-12	0	4.95
2021-01	0	2.56
2021-02	0	3.25
2021-03	0	7.58
2021-04	0	6.11
2021-05	0	2.96
2021-06	0	10.58
2021-07	0	9.17
2021-08	0	6.3
2021-09	0	2.95
2021-10	0	7.23
2021-11	0	8.37
2021-12	0	5.81
2022-01	0	5.88
2022-02	0	4.1
2022-03	0	5.24
2022-04	0	2.56
2022-05	0	5.49
2022-06	0	3.81
2022-07	0	4.41
2022-08	0	4.51
2022-09	0	7.54
2022-10	0	6.75
2022-11	0	10
2022-12	0	3.91
2023-01	0	9.76
2023-02	0	5.79
2023-03	0	3.53
2023-04	0	2.84
2023-05	0	6.33
2023-06	0	7.64
2023-07	0	6
2023-08	0	10.31
2023-09	0	7.81
2023-10	0	7.13
2023-11	0	6.86
2023-12	0	4.27
2024-01	0	5.94
2024-02	0	18.12
2024-03	0	5.54
2024-04	0	9.95
2024-05	0	11.78
2024-06	0	6.74
2024-07	0	5.2
2024-08	0	4.32
2024-09	0	4.81
2024-10	0	2.9
2024-11	0	3.09
2024-12	0	2
2025-01	0	1.71
2025-02	0	1.29
2025-03	0	4
2025-04	0	1.28
2025-05	0	1.96
2025-06	0	2
2025-07	0	7.04
2025-08	0	2.79
2025-09	0	1.11
2025-10	0	1
2025-11	0	1.16
2025-12	0	1.74
2026-01	0	4.21
2026-02	0	2.52
2026-03	0	1.65
2026-04	0	13.87
2026-05	0	1.4
2026-06	0	1.95

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

Failure-mode summaryAI-generated

1 linked report narrative available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2019-01-22	2939274-2019-55991	Malfunction	Available	exact di

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2023-12-05	VAI	Voluntary action indicated	Instrumed International Inc	5
2022-06-28	VAI	Voluntary action indicated	Avalign Integrated Medical Solutions, Inc.	3
2019-11-20	VAI	Voluntary action indicated	Instrumed International Inc	2
2018-10-25	NAI	No action indicated	Instrumed GmbH	0
2016-11-30	NAI	No action indicated	Instrumed International Inc	0
2015-09-22	NAI	No action indicated	Millennium Surgical Corp	0
2015-01-29	NAI	No action indicated	Instrumed GmbH	0
2014-03-28	WL	Warning Letter	Instrumed GmbH	—
2013-08-20	VAI	Voluntary action indicated	Instrumed International Inc	17
2013-08-01	OAI	Official action indicated	Instrumed GmbH	0
2013-04-24	VAI	Voluntary action indicated	Avalign Integrated Medical Solutions, Inc.	4
2011-02-28	NAI	No action indicated	Instrumed International Inc	0

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