SMARTLOCK · 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.

23 linked reportsInjury 19Malfunction 4

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	0	1.41
2019-02	0	1.33
2019-03	0	2.41
2019-04	0	2.95
2019-05	0	3.31
2019-06	0	1.41
2019-07	0	1.76
2019-08	0	2
2019-09	0	2.17
2019-10	0	2.53
2019-11	0	1.72
2019-12	0	2.35
2020-01	0	2.54
2020-02	0	1.83
2020-03	0	2.06
2020-04	0	2.13
2020-05	0	2.31
2020-06	0	2
2020-07	0	2.17
2020-08	0	2.21
2020-09	0	2.06
2020-10	0	2.22
2020-11	0	1.71
2020-12	0	1.9
2021-01	0	2.13
2021-02	0	1.25
2021-03	0	2
2021-04	0	3.33
2021-05	0	4.09
2021-06	0	1.93
2021-07	0	1.33
2021-08	0	3.31
2021-09	1	1.58
2021-10	0	2.12
2021-11	0	2
2021-12	0	3.93
2022-01	0	2
2022-02	0	2.67
2022-03	0	3.5
2022-04	0	2.36
2022-05	0	1.77
2022-06	0	2.5
2022-07	0	2.16
2022-08	0	2.15
2022-09	0	1.5
2022-10	0	6.64
2022-11	0	2.27
2022-12	0	3.37
2023-01	0	2.67
2023-02	0	3.26
2023-03	0	2.67
2023-04	0	1.5
2023-05	0	2.88
2023-06	0	4.15
2023-07	0	3.81
2023-08	0	3.07
2023-09	0	2.58
2023-10	0	1.44
2023-11	0	2.68
2023-12	0	2.05
2024-01	0	2.89
2024-02	0	2.67
2024-03	0	2.23
2024-04	0	2.61
2024-05	0	2.29
2024-06	0	1.83
2024-07	0	1.55
2024-08	0	1.6
2024-09	0	2.07
2024-10	0	2.29
2024-11	0	2.75
2024-12	0	1.7
2025-01	0	1.5
2025-02	0	1.38
2025-03	0	2
2025-04	0	1.9
2025-05	0	2.27
2025-06	1	2
2025-07	0	4.1
2025-08	0	2.57
2025-09	0	1.69
2025-10	5	1.95
2025-11	0	1.53
2025-12	8	4.38
2026-01	0	1.57
2026-02	1	2.45
2026-03	1	1.11
2026-04	5	3.09
2026-05	1	2.1
2026-06	0	3.56

This device (reports/month)Average device in JEY (reports/device/month)

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-05-28	0008010177-2026-00067	Injury	Available	exact di
2026-04-30	0008010177-2026-00061	Injury	Available	exact di
2026-04-29	0008010177-2026-00060	Injury	Available	exact di
2026-04-13	0008010177-2026-00056	Injury	Available	exact di
2026-04-09	0008010177-2026-00049	Injury	Available	exact di
2026-04-02	0008010177-2026-00048	Injury	Available	exact di
2026-03-05	0008010177-2026-00028	Injury	Available	exact di
2026-02-06	0008010177-2026-00008	Injury	Available	exact di
2025-12-18	0008010177-2025-00179	Injury	Available	exact di
2025-12-18	0008010177-2025-00176	Injury	Available	exact di
2025-12-18	0008010177-2025-00177	Injury	Available	exact di
2025-12-18	0008010177-2025-00175	Injury	Available	exact di
2025-12-17	0008010177-2025-00170	Malfunction	Available	exact di
2025-12-17	0008010177-2025-00171	Malfunction	Available	exact di
2025-12-17	0008010177-2025-00169	Malfunction	Available	exact di

Showing 1–15 of 23

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility
2025-02-27	NAI	No action indicated	Stryker Leibinger GmbH & Co. KG
2017-07-27	NAI	No action indicated	Stryker Leibinger GmbH & Co. KG
2013-11-14	NAI	No action indicated	Stryker Leibinger GmbH & Co. KG

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