X3 · 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.

67 linked reportsInjury 66Malfunction 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	2.38
2019-02	4	2.17
2019-03	1	2.44
2019-04	1	2.41
2019-05	0	1.91
2019-06	3	1.68
2019-07	3	1.62
2019-08	2	2
2019-09	0	1.95
2019-10	2	2.18
2019-11	2	2.02
2019-12	1	2.22
2020-01	1	2.6
2020-02	0	2.2
2020-03	1	2.76
2020-04	0	2.1
2020-05	3	1.96
2020-06	1	1.9
2020-07	0	2.35
2020-08	1	1.97
2020-09	1	2.43
2020-10	1	2.38
2020-11	4	2.11
2020-12	0	2.16
2021-01	1	2.24
2021-02	1	1.96
2021-03	0	1.94
2021-04	2	1.96
2021-05	1	1.97
2021-06	1	2.23
2021-07	1	2.25
2021-08	0	2.21
2021-09	1	2.45
2021-10	0	2.19
2021-11	1	1.98
2021-12	2	2.12
2022-01	0	2.01
2022-02	0	2.06
2022-03	2	2.07
2022-04	2	2.05
2022-05	0	2.19
2022-06	3	2.09
2022-07	1	2.05
2022-08	1	2.11
2022-09	1	2.2
2022-10	2	2.13
2022-11	0	2.22
2022-12	3	2.07
2023-01	1	2.26
2023-02	0	2.08
2023-03	0	2.19
2023-04	0	2.24
2023-05	2	2.13
2023-06	0	2.26
2023-07	1	2.16
2023-08	0	1.92
2023-09	0	1.97
2023-10	0	1.67
2023-11	0	1.64
2023-12	0	1.74
2024-01	1	1.72
2024-02	0	2.06
2024-03	2	1.97
2024-04	0	1.82
2024-05	0	2.22
2024-06	0	1.97
2024-07	0	1.71
2024-08	0	2.03
2024-09	0	1.97
2024-10	0	1.81
2024-11	0	1.79
2024-12	0	1.62
2025-01	0	1.99
2025-02	0	1.58
2025-03	0	1.8
2025-04	0	1.84
2025-05	0	1.78
2025-06	0	1.87
2025-07	0	1.81
2025-08	0	1.78
2025-09	0	1.67
2025-10	0	1.72
2025-11	0	1.8
2025-12	0	1.92
2026-01	1	1.92
2026-02	0	1.72
2026-03	0	1.95
2026-04	0	1.97
2026-05	0	1.76
2026-06	0	1.8

This device (reports/month)Average device in 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
2026-01-16	0002249697-2026-00032	Injury	Available	exact di
2024-03-22	0002249697-2024-00488	Injury	Available	exact di
2024-03-12	0002249697-2024-00384	Injury	Available	exact di
2024-01-12	0002249697-2024-00072	Injury	Available	exact di
2023-07-26	0002249697-2023-00842	Injury	Available	exact di
2023-05-16	0002249697-2023-00533	Injury	Available	exact di
2023-05-09	0002249697-2023-00491	Injury	Available	exact di
2023-01-13	0002249697-2023-00038	Injury	Available	exact di
2022-12-13	0002249697-2022-01814	Injury	Available	exact di
2022-12-12	0002249697-2022-01802	Injury	Available	exact di
2022-12-06	0002249697-2022-01774	Injury	Available	exact di
2022-10-20	0002249697-2022-01521	Injury	Available	exact di
2022-10-12	0002249697-2022-01475	Injury	Available	exact di
2022-09-16	0002249697-2022-01357	Injury	Available	exact di
2022-08-28	0002249697-2022-01257	Injury	Available	exact di

Showing 1–15 of 67

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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