Zero-P · 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.

4 linked reportsMalfunction 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	1
2019-02	0	1
2019-03	0	2
2019-04	1	1.71
2019-05	0	1.56
2019-06	0	1.25
2019-07	0	1.67
2019-08	0	3
2019-09	0	1.67
2019-10	0	2
2019-11	0	1.2
2019-12	0	1.5
2020-01	0	8
2020-02	0	1.4
2020-03	0	1.2
2020-04	0	1.2
2020-05	0	1.33
2020-06	0	1
2020-07	0	2.17
2020-08	0	1
2020-09	0	2.33
2020-10	0	1.63
2020-11	0	1.33
2020-12	0	1.33
2021-01	0	1.25
2021-02	0	3.5
2021-03	0	1.5
2021-04	0	1
2021-05	0	3.92
2021-06	0	1.25
2021-07	0	1
2021-08	0	1.67
2021-09	2	1.5
2021-10	0	1
2021-11	0	1
2021-12	0	2
2022-01	0	1
2022-02	0	1
2022-03	0	1.14
2022-04	0	1
2022-05	0	1.4
2022-06	0	1.78
2022-07	0	1.14
2022-08	0	1.13
2022-09	0	2
2022-10	0	1
2022-11	0	1.33
2022-12	0	2.25
2023-01	0	3
2023-02	0	2
2023-03	0	2.83
2023-04	0	2
2023-05	0	1.33
2023-06	0	1.67
2023-07	0	1.5
2023-08	0	1.36
2023-10	0	2
2023-11	0	1
2023-12	0	1.5
2024-01	0	1.57
2024-02	0	1.5
2024-03	0	1.88
2024-04	0	2
2024-05	0	1.77
2024-06	0	3.38
2024-07	0	1
2024-08	0	1.2
2024-09	0	1.57
2024-10	0	1.5
2024-11	0	1.25
2024-12	0	1.25
2025-01	0	1.5
2025-02	0	2.2
2025-03	0	2.56
2025-04	0	1.75
2025-05	0	1.8
2025-06	0	2.4
2025-07	0	2.11
2025-08	0	1.4
2025-09	0	1.75
2025-10	0	1.57
2025-11	0	2.2
2025-12	0	1.4
2026-01	0	1.71
2026-02	0	1.71
2026-03	1	1.56
2026-04	0	1.25
2026-05	0	4
2026-06	0	3.5

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-03-06	8030965-2026-02306	Malfunction	Available	exact di
2021-09-29	8030965-2021-08137	Malfunction	Available	exact di
2019-04-08	2939274-2019-57345	Malfunction	Available	exact di

Showing the most recent 3 of 4 linked reports.

Regulatory clearances

Predicate lineage

K072981

Cited as predicate by: K113796, K150673, K152532, K153250, K172424, K253213

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2017-08-08	NAI	No action indicated	Synthes GmbH	0
2017-01-18	NAI	No action indicated	Synthes (USA), LLC	0
2015-05-08	VAI	Voluntary action indicated	Synthes (USA), LLC	2
2013-11-13	VAI	Voluntary action indicated	Synthes, Inc.	1
2013-05-16	NAI	No action indicated	Synthes, Inc.	0
2012-10-19	VAI	Voluntary action indicated	Synthes, Inc.	1
2012-02-16	WL	Warning Letter	Synthes, Inc.	—
2012-02-01	NAI	No action indicated	Synthes (USA), LLC	0
2011-09-15	OAI	Official action indicated	Synthes, Inc.	10

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