Optivac Nozzle Slim · 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	2.25
2019-02	0	8
2019-03	0	1.5
2019-04	0	4.83
2019-05	0	3
2019-06	0	8.5
2019-07	0	3.2
2019-08	0	19.5
2019-09	0	16.67
2019-10	0	20.25
2019-11	0	36
2019-12	0	26.5
2020-01	0	17.75
2020-02	0	5.5
2020-03	0	14.5
2020-04	0	5
2020-05	0	2
2020-06	0	8.33
2020-07	0	2.86
2020-08	0	3
2020-09	0	4
2020-10	0	2
2020-11	0	14
2020-12	0	7.5
2021-01	0	3
2021-02	0	14
2021-03	0	13
2021-04	0	10.25
2021-05	0	18
2021-06	0	3.5
2021-07	0	7.67
2021-08	0	10
2021-09	0	3.33
2021-10	0	1.67
2021-11	0	2.2
2021-12	0	4.5
2022-01	0	1.33
2022-02	0	1.5
2022-03	0	1.5
2022-04	0	1.67
2022-05	0	2
2022-06	0	3
2022-07	0	4.33
2022-08	0	1.5
2022-09	0	1
2022-10	0	2.8
2022-11	0	1
2022-12	0	2
2023-01	0	1.25
2023-02	0	2
2023-03	0	2
2023-04	0	1.14
2023-05	0	2
2023-06	0	2.25
2023-07	0	1.33
2023-08	0	1.67
2023-09	0	2.67
2023-10	0	1
2023-11	0	4.5
2023-12	0	1
2024-01	0	1
2024-02	0	2
2024-03	0	2.67
2024-04	0	1
2024-05	1	1.5
2024-07	0	1
2024-08	0	1.5
2024-09	0	2.5
2024-10	0	1.25
2024-11	0	4
2024-12	0	8
2025-01	0	1.4
2025-02	0	1
2025-03	0	2.67
2025-04	0	1.67
2025-05	0	3
2025-06	0	2.89
2025-07	0	1.67
2025-08	0	8.5
2025-09	0	2
2025-10	0	3.83
2025-11	0	10.5
2025-12	0	3.5
2026-01	0	1.33
2026-02	0	2
2026-03	0	3
2026-04	0	1.33
2026-05	0	1
2026-06	0	1

This device (reports/month)Average device in KIH (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
2024-05-13	3006946279-2024-00025	Malfunction	Available	exact di

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2023-11-09	VAI	Voluntary action indicated	Biomet, Inc.	0
2023-11-09	VAI	Voluntary action indicated	Biomet, Inc.	0
2020-01-30	VAI	Voluntary action indicated	Biomet, Inc.	8
2020-01-30	VAI	Voluntary action indicated	Biomet, Inc.	8
2018-08-24	WL	Warning Letter	Biomet, Inc.	—
2018-08-24	WL	Warning Letter	Biomet, Inc.	—
2018-04-24	OAI	Official action indicated	Biomet, Inc.	11
2018-04-24	OAI	Official action indicated	Biomet, Inc.	11
2017-08-17	NAI	No action indicated	Zhejiang Biomet Medical Products Co. Ltd.	0
2017-08-03	VAI	Voluntary action indicated	Biomet UK Ltd.	4
2017-02-10	NAI	No action indicated	Biomet	0
2017-02-03	NAI	No action indicated	Biomet France SARL	0
2016-11-22	OAI	Official action indicated	Biomet, Inc.	14
2016-11-22	OAI	Official action indicated	Biomet, Inc.	14
2016-03-24	NAI	No action indicated	CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.	0
2015-06-03	WL	Warning Letter	Zhejiang Biomet Medical Products Co. Ltd.	—
2015-03-18	VAI	Voluntary action indicated	Biomet UK Ltd.	2
2015-01-22	OAI	Official action indicated	Zhejiang Biomet Medical Products Co. Ltd.	0
2014-06-30	VAI	Voluntary action indicated	Biomet, Inc.	2
2014-06-30	VAI	Voluntary action indicated	Biomet, Inc.	2
2013-01-18	NAI	No action indicated	Biomet	0
2010-07-27	WL	Warning Letter	Biomet, Inc.	—
2010-07-27	WL	Warning Letter	Biomet, Inc.	—
2010-03-26	NAI	No action indicated	Biomet, Inc.	0
2010-03-26	NAI	No action indicated	Biomet, Inc.	0

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