Accolade · 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.

49 linked reportsInjury 49

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	2.64
2019-02	0	2.27
2019-03	0	2.57
2019-04	3	2.47
2019-05	1	2
2019-06	0	1.68
2019-07	0	1.71
2019-08	0	1.96
2019-09	1	2.1
2019-10	2	2.28
2019-11	0	1.95
2019-12	0	2.19
2020-01	0	2.48
2020-02	0	2.25
2020-03	1	2.83
2020-04	1	2.01
2020-05	0	1.99
2020-06	0	1.87
2020-07	0	2.3
2020-08	0	1.81
2020-09	0	2.22
2020-10	4	2.23
2020-11	0	2.07
2020-12	1	2.12
2021-01	0	2.22
2021-02	0	1.86
2021-03	1	1.88
2021-04	0	1.87
2021-05	1	1.83
2021-06	0	2.27
2021-07	0	2.13
2021-08	0	2.07
2021-09	1	2.19
2021-10	2	2.04
2021-11	0	1.88
2021-12	1	2.09
2022-01	1	1.88
2022-02	0	1.91
2022-03	0	1.95
2022-04	1	1.97
2022-05	0	1.97
2022-06	1	2.03
2022-07	1	1.92
2022-08	1	1.98
2022-09	0	2.01
2022-10	2	1.96
2022-11	1	2.04
2022-12	1	1.95
2023-01	0	2.09
2023-02	0	1.95
2023-03	0	2.13
2023-04	1	2.07
2023-05	0	2.02
2023-06	0	2.06
2023-07	0	2
2023-08	0	1.89
2023-09	2	1.9
2023-10	1	1.58
2023-11	1	1.55
2023-12	0	1.64
2024-01	1	1.67
2024-02	0	1.92
2024-03	0	1.89
2024-04	1	1.68
2024-05	1	2.01
2024-06	0	1.84
2024-07	1	1.66
2024-08	1	1.84
2024-09	1	1.93
2024-10	1	1.72
2024-11	0	1.63
2024-12	1	1.52
2025-01	1	1.78
2025-02	0	1.47
2025-03	1	1.76
2025-04	0	1.77
2025-05	0	1.62
2025-06	0	1.76
2025-07	1	1.78
2025-08	0	1.62
2025-09	1	1.67
2025-10	1	1.68
2025-11	0	1.71
2025-12	0	1.8
2026-01	0	1.88
2026-02	0	1.57
2026-03	0	1.85
2026-04	0	1.78
2026-05	1	1.6
2026-06	0	1.68

This device (reports/month)Average device in JDI, KWL, KWY, KWZ, LPH, LWJ, LZO, MAY, MBL, 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
2026-05-06	0002249697-2026-00374	Injury	Available	exact di
2025-10-31	0002249697-2025-01274	Injury	Available	exact di
2025-09-24	0002249697-2025-01023	Injury	Available	exact di
2025-07-11	0002249697-2025-00690	Injury	Available	exact di
2025-03-27	0002249697-2025-00336	Injury	Available	exact di
2025-01-06	0002249697-2025-00005	Injury	Available	exact di
2024-12-10	0002249697-2024-01698	Injury	Available	exact di
2024-10-23	0002249697-2024-01448	Injury	Available	exact di
2024-09-06	0002249697-2024-01213	Injury	Available	exact di
2024-08-21	0002249697-2024-01151	Injury	Available	exact di
2024-07-22	0002249697-2024-01011	Injury	Available	exact di
2024-05-31	0002249697-2024-00820	Injury	Available	exact di
2024-04-03	0002249697-2024-00548	Injury	Available	exact di
2024-01-08	0002249697-2024-00040	Injury	Available	exact di
2023-11-02	0002249697-2023-01312	Injury	Available	exact di

Showing 1–15 of 49

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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