Alumina · 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 reportInjury 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	2.72
2019-02	0	2.45
2019-03	0	2.79
2019-04	0	2.65
2019-05	0	2.07
2019-06	0	1.85
2019-07	0	1.73
2019-08	0	2.19
2019-09	0	2.2
2019-10	0	2.5
2019-11	0	2.2
2019-12	0	2.55
2020-01	0	3.08
2020-02	0	2.52
2020-03	0	3.17
2020-04	0	2.37
2020-05	0	2.26
2020-06	0	2.13
2020-07	0	2.62
2020-08	0	2.21
2020-09	0	2.8
2020-10	0	2.76
2020-11	0	2.4
2020-12	0	2.47
2021-01	0	2.52
2021-02	0	2.24
2021-03	0	2.2
2021-04	0	2.17
2021-05	0	2.19
2021-06	0	2.49
2021-07	0	2.58
2021-08	0	2.56
2021-09	0	2.75
2021-10	0	2.46
2021-11	0	2.22
2021-12	0	2.46
2022-01	0	2.31
2022-02	0	2.33
2022-03	0	2.38
2022-04	0	2.3
2022-05	0	2.46
2022-06	0	2.32
2022-07	0	2.32
2022-08	0	2.33
2022-09	0	2.44
2022-10	0	2.4
2022-11	0	2.48
2022-12	0	2.48
2023-01	0	2.63
2023-02	0	2.34
2023-03	0	2.47
2023-04	0	2.44
2023-05	0	2.35
2023-06	0	2.45
2023-07	0	2.31
2023-08	0	2.02
2023-09	0	2.04
2023-10	0	1.8
2023-11	0	1.78
2023-12	0	1.89
2024-01	0	1.84
2024-02	0	2.21
2024-03	0	2.01
2024-04	0	1.91
2024-05	0	2.24
2024-06	0	2
2024-07	0	1.82
2024-08	0	2.05
2024-09	0	2.05
2024-10	0	1.87
2024-11	0	1.99
2024-12	0	1.71
2025-01	0	2.18
2025-02	0	1.66
2025-03	0	1.85
2025-04	0	1.95
2025-05	0	1.94
2025-06	0	1.97
2025-07	0	1.92
2025-08	0	1.94
2025-09	0	1.75
2025-10	0	1.84
2025-11	0	1.9
2025-12	0	1.99
2026-01	0	2.04
2026-02	0	1.83
2026-03	0	1.98
2026-04	0	2.12
2026-05	0	1.92
2026-06	0	1.88

This device (reports/month)Average device in LZO (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
2019-01-03	0002249697-2019-00025	Injury	Available	exact di

Regulatory clearances

Predicate lineage

K023901

Cited as predicate by: K153345

K173499

Cited as predicate by: K191414, K193429, K233498

K243784

Cited as predicate by: K250989, K252459

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
2023-12-01	VAI	Voluntary action indicated	Howmedica Osteonics Corp.	1
2021-06-22	NAI	No action indicated	Howmedica Osteonics Corp.	0
2015-03-09	VAI	Voluntary action indicated	Howmedica Osteonics Corp.	3
2013-04-16	VAI	Voluntary action indicated	Howmedica Osteonics Corp.	3
2010-01-15	NAI	No action indicated	Howmedica Osteonics Corp.	0

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