CONMED · 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	0	6.86
2019-02	0	4.35
2019-03	0	4.42
2019-04	0	6.12
2019-05	0	4.8
2019-06	0	5.04
2019-07	0	5.86
2019-08	0	6.1
2019-09	0	4.99
2019-10	0	5.85
2019-11	0	5.62
2019-12	0	5.41
2020-01	0	4.81
2020-02	0	5.57
2020-03	0	5.68
2020-04	0	3.57
2020-05	0	3.76
2020-06	0	5.14
2020-07	0	6.56
2020-08	0	4.64
2020-09	0	5.86
2020-10	0	5.55
2020-11	0	5.14
2020-12	1	5.31
2021-01	0	5.17
2021-02	0	4.89
2021-03	0	5.7
2021-04	0	5.26
2021-05	0	5.14
2021-06	0	5.83
2021-07	0	4.89
2021-08	0	4.3
2021-09	0	4.77
2021-10	0	6.17
2021-11	0	5.57
2021-12	0	5.56
2022-01	0	5.04
2022-02	0	5.15
2022-03	0	5.75
2022-04	0	4.98
2022-05	0	5.78
2022-06	0	6.3
2022-07	0	4.36
2022-08	0	4.59
2022-09	0	5
2022-10	0	4.76
2022-11	0	4.61
2022-12	0	4.04
2023-01	0	5.52
2023-02	0	4.59
2023-03	0	4.87
2023-04	0	4.78
2023-05	0	5.14
2023-06	0	4.78
2023-07	0	4.82
2023-08	0	4.44
2023-09	0	5.23
2023-10	0	5.1
2023-11	0	4.38
2023-12	0	4.79
2024-01	0	5.54
2024-02	0	5.46
2024-03	0	6.16
2024-04	0	6.04
2024-05	0	6.28
2024-06	0	5.39
2024-07	0	5.05
2024-08	0	5.01
2024-09	0	5.19
2024-10	0	5.7
2024-11	0	5.29
2024-12	0	4.06
2025-01	0	5.17
2025-02	0	4.46
2025-03	0	6.28
2025-04	0	4.39
2025-05	0	5.16
2025-06	0	5.08
2025-07	0	5.2
2025-08	0	5.45
2025-09	0	4.85
2025-10	0	5.14
2025-11	0	5.55
2025-12	0	5.81
2026-01	0	5.63
2026-02	0	5.98
2026-03	0	6.2
2026-04	0	5.43
2026-05	0	6.19
2026-06	0	5.56

This device (reports/month)Average device in GEI (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
2020-12-15	1320894-2020-00549	Malfunction	Available	catalog number

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2026-05-13	NAI	No action indicated	Biorez, Inc	0
2026-04-06	VAI	Voluntary action indicated	ConMed Corporation	6
2026-04-06	VAI	Voluntary action indicated	ConMed Corporation	6
2023-12-14	NAI	No action indicated	Linvatec Corp.	0
2023-08-04	VAI	Voluntary action indicated	Biorez, Inc	1
2022-11-10	NAI	No action indicated	ConMed Corporation	0
2022-11-10	NAI	No action indicated	ConMed Corporation	0
2022-07-13	NAI	No action indicated	ConMed Corporation	0
2022-07-13	NAI	No action indicated	ConMed Corporation	0
2020-09-22	VAI	Voluntary action indicated	ConMed Corporation	0
2020-09-22	VAI	Voluntary action indicated	ConMed Corporation	0
2019-10-17	NAI	No action indicated	ConMed Corporation	0
2019-10-17	NAI	No action indicated	ConMed Corporation	0
2017-02-03	VAI	Voluntary action indicated	ConMed Corporation	2
2017-02-03	VAI	Voluntary action indicated	ConMed Corporation	2
2017-01-23	NAI	No action indicated	Conmed	0
2016-02-03	VAI	Voluntary action indicated	ConMed Corporation	5
2016-02-03	VAI	Voluntary action indicated	ConMed Corporation	5
2014-11-18	NAI	No action indicated	ConMed Corporation	0
2014-11-18	NAI	No action indicated	ConMed Corporation	0
2014-01-29	WL	Warning Letter	ConMed Corporation	—
2014-01-29	WL	Warning Letter	ConMed Corporation	—

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