LFIT · 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.

59 linked reportsInjury 57Malfunction 2

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	4	2.58
2019-02	2	2.2
2019-03	1	2.34
2019-04	1	2.33
2019-05	0	1.91
2019-06	1	1.65
2019-07	0	1.73
2019-08	1	1.9
2019-09	2	1.97
2019-10	1	2.11
2019-11	0	1.69
2019-12	1	1.96
2020-01	2	2.17
2020-02	4	2.16
2020-03	0	2.7
2020-04	0	1.87
2020-05	1	1.97
2020-06	2	1.7
2020-07	1	2.13
2020-08	0	1.63
2020-09	0	1.84
2020-10	0	1.97
2020-11	0	1.88
2020-12	2	1.94
2021-01	1	1.98
2021-02	0	1.7
2021-03	2	1.76
2021-04	0	1.66
2021-05	1	1.64
2021-06	2	2.05
2021-07	1	1.88
2021-08	0	1.77
2021-09	1	1.9
2021-10	0	1.8
2021-11	0	1.76
2021-12	0	1.95
2022-01	2	1.64
2022-02	3	1.94
2022-03	0	1.68
2022-04	2	1.85
2022-05	1	1.75
2022-06	0	1.8
2022-07	0	1.77
2022-08	2	1.9
2022-09	1	1.84
2022-10	0	1.78
2022-11	0	1.88
2022-12	0	1.73
2023-01	1	1.93
2023-02	0	1.75
2023-03	0	1.8
2023-04	0	1.86
2023-05	0	1.89
2023-06	0	1.94
2023-07	1	1.96
2023-08	0	1.91
2023-09	0	1.94
2023-10	2	1.48
2023-11	1	1.48
2023-12	0	1.51
2024-01	1	1.61
2024-02	0	1.74
2024-03	1	1.95
2024-04	1	1.62
2024-05	0	2.09
2024-06	1	1.85
2024-07	0	1.61
2024-08	1	1.84
2024-09	0	1.93
2024-10	0	1.6
2024-11	1	1.44
2024-12	1	1.46
2025-01	1	1.52
2025-02	0	1.38
2025-03	0	1.67
2025-04	0	1.69
2025-05	0	1.39
2025-06	0	1.63
2025-07	0	1.65
2025-08	0	1.44
2025-09	1	1.63
2025-10	0	1.64
2025-11	0	1.7
2025-12	0	1.69
2026-01	0	1.84
2026-02	0	1.46
2026-03	0	1.91
2026-04	0	1.65
2026-05	0	1.59
2026-06	0	1.56

This device (reports/month)Average device in JDI, KWY, LWJ (reports/device/month)

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-09-24	0002249697-2025-01024	Injury	Available	exact di
2025-01-06	0002249697-2025-00024	Injury	Available	exact di
2024-12-11	0002249697-2024-01709	Injury	Available	exact di
2024-11-06	0002249697-2024-01507	Injury	Available	exact di
2024-08-13	0002249697-2024-01119	Injury	Available	exact di
2024-06-30	0002249697-2024-00935	Injury	Available	exact di
2024-04-23	0002249697-2024-00624	Injury	Available	exact di
2024-03-20	0002249697-2024-00472	Injury	Available	exact di
2024-01-08	0002249697-2024-00038	Injury	Available	exact di
2023-11-04	0002249697-2023-01330	Injury	Available	exact di
2023-10-05	0002249697-2023-01134	Injury	Available	exact di
2023-10-03	0002249697-2023-01112	Injury	Available	exact di
2023-07-12	0002249697-2023-00767	Injury	Available	exact di
2023-01-30	0002249697-2023-00089	Injury	Available	exact di
2022-09-30	0002249697-2022-01418	Injury	Available	exact di

Showing 1–15 of 59

Regulatory clearances

None linked.

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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