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.

52 linked reportsInjury 52

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	3	3.08
2019-02	0	2.63
2019-03	0	2.97
2019-04	1	2.81
2019-05	1	2.18
2019-06	1	1.88
2019-07	0	1.89
2019-08	2	2.19
2019-09	0	2.43
2019-10	5	2.63
2019-11	0	2.22
2019-12	0	2.52
2020-01	1	2.92
2020-02	2	2.58
2020-03	1	3.32
2020-04	0	2.32
2020-05	1	2.27
2020-06	0	2.11
2020-07	0	2.59
2020-08	1	2.09
2020-09	0	2.62
2020-10	0	2.61
2020-11	1	2.37
2020-12	0	2.36
2021-01	0	2.5
2021-02	0	2.1
2021-03	0	2.09
2021-04	0	2.11
2021-05	0	2.06
2021-06	0	2.54
2021-07	1	2.38
2021-08	2	2.33
2021-09	2	2.47
2021-10	0	2.25
2021-11	0	2.15
2021-12	0	2.37
2022-01	1	2.13
2022-02	0	2.16
2022-03	0	2.22
2022-04	1	2.21
2022-05	1	2.18
2022-06	0	2.29
2022-07	0	2.15
2022-08	1	2.23
2022-09	1	2.24
2022-10	1	2.21
2022-11	1	2.3
2022-12	1	2.24
2023-01	0	2.27
2023-02	0	2.19
2023-03	1	2.41
2023-04	0	2.32
2023-05	0	2.26
2023-06	0	2.35
2023-07	0	2.19
2023-08	0	2.03
2023-09	3	2.04
2023-10	0	1.71
2023-11	1	1.67
2023-12	0	1.76
2024-01	2	1.77
2024-02	0	2.11
2024-03	0	2.01
2024-04	2	1.82
2024-05	0	2.19
2024-06	0	1.99
2024-07	0	1.77
2024-08	1	1.97
2024-09	1	2.08
2024-10	2	1.83
2024-11	1	1.79
2024-12	1	1.61
2025-01	0	1.97
2025-02	1	1.56
2025-03	0	1.79
2025-04	0	1.84
2025-05	0	1.75
2025-06	0	1.87
2025-07	0	1.83
2025-08	1	1.75
2025-09	0	1.76
2025-10	0	1.74
2025-11	0	1.83
2025-12	0	1.93
2026-01	0	2
2026-02	0	1.69
2026-03	1	2.01
2026-04	0	1.92
2026-05	1	1.76
2026-06	0	1.79

This device (reports/month)Average device in JDI, LPH, LZO, MEH (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
2026-05-27	0002249697-2026-00442	Injury	Available	exact di
2026-03-03	0002249697-2026-00154	Injury	Available	exact di
2025-08-26	0002249697-2025-00919	Injury	Available	exact di
2025-02-05	0002249697-2025-00145	Injury	Available	exact di
2024-12-10	0002249697-2024-01697	Injury	Available	exact di
2024-11-11	0002249697-2024-01533	Injury	Available	exact di
2024-10-29	0002249697-2024-01471	Injury	Available	exact di
2024-10-16	0002249697-2024-01422	Injury	Available	exact di
2024-09-17	0002249697-2024-01294	Injury	Available	exact di
2024-08-27	0002249697-2024-01172	Injury	Available	exact di
2024-04-30	0002249697-2024-00669	Injury	Available	exact di
2024-04-12	0002249697-2024-00588	Injury	Available	exact di
2024-01-08	0002249697-2024-00044	Injury	Available	exact di
2024-01-05	0002249697-2024-00028	Injury	Available	exact di
2023-11-04	0002249697-2023-01332	Injury	Available	exact di

Showing 1–15 of 52

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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