Tornier Flex Shoulder System · 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.

69 linked reportsInjury 69

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	1.68
2019-02	0	1.59
2019-03	0	1.68
2019-04	0	1.52
2019-05	0	1.76
2019-06	0	1.87
2019-07	0	1.41
2019-08	0	1.97
2019-09	0	1.48
2019-10	0	1.8
2019-11	0	1.62
2019-12	0	1.74
2020-01	0	1.89
2020-02	0	2.15
2020-03	0	1.76
2020-04	0	1.72
2020-05	0	1.43
2020-06	0	1.8
2020-07	0	1.91
2020-08	0	1.63
2020-09	0	1.92
2020-10	0	2.1
2020-11	0	1.85
2020-12	0	1.82
2021-01	0	1.95
2021-02	0	1.82
2021-03	0	1.98
2021-04	0	1.76
2021-05	0	1.76
2021-06	0	1.63
2021-07	0	1.87
2021-08	0	2.03
2021-09	0	1.66
2021-10	0	1.71
2021-11	0	1.97
2021-12	0	1.93
2022-01	1	2.04
2022-02	2	2.04
2022-03	1	1.73
2022-04	4	2.04
2022-05	1	1.88
2022-06	1	2.01
2022-07	0	2.05
2022-08	0	2
2022-09	1	1.84
2022-10	0	1.87
2022-11	0	2.02
2022-12	0	1.82
2023-01	2	1.72
2023-02	2	1.94
2023-03	0	1.93
2023-04	0	1.92
2023-05	1	2
2023-06	0	2.26
2023-07	0	2.07
2023-08	2	1.67
2023-09	2	1.51
2023-10	0	1.56
2023-11	1	1.61
2023-12	0	1.41
2024-01	0	1.99
2024-02	2	1.76
2024-03	5	1.68
2024-04	5	1.77
2024-05	1	1.72
2024-06	2	1.9
2024-07	3	1.6
2024-08	5	1.7
2024-09	2	1.71
2024-10	2	1.61
2024-11	0	1.58
2024-12	2	1.63
2025-01	1	1.72
2025-02	0	1.56
2025-03	0	1.84
2025-04	1	1.63
2025-05	2	1.75
2025-06	1	1.83
2025-07	0	1.71
2025-08	2	1.53
2025-09	1	1.51
2025-10	1	1.62
2025-11	0	1.71
2025-12	0	2.11
2026-01	3	1.87
2026-02	1	1.8
2026-03	2	1.75
2026-04	1	1.7
2026-05	3	1.75
2026-06	0	1.68

This device (reports/month)Average device in KWS (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
2026-05-20	3000931034-2026-00425	Injury	Available	exact di
2026-05-06	3000931034-2026-00395	Injury	Available	exact di
2026-05-05	3000931034-2026-00394	Injury	Available	exact di
2026-04-17	3000931034-2026-00365	Injury	Available	exact di
2026-03-30	3000931034-2026-00318	Injury	Available	exact di
2026-03-05	3000931034-2026-00244	Injury	Available	exact di
2026-02-16	3000931034-2026-00161	Injury	Available	exact di
2026-01-28	3000931034-2026-00101	Injury	Available	exact di
2026-01-28	3000931034-2026-00099	Injury	Available	exact di
2026-01-14	3000931034-2026-00070	Injury	Available	exact di
2025-10-20	3000931034-2025-00565	Injury	Available	exact di
2025-09-09	3000931034-2025-00485	Injury	Available	exact di
2025-08-08	3000931034-2025-00443	Injury	Available	exact di
2025-08-07	3000931034-2025-00430	Injury	Available	exact di
2025-06-05	3000931034-2025-00302	Injury	Available	exact di

Showing the most recent 67 of 69 linked reports.

Showing 1–15 of 67

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2015-07-15	NAI	No action indicated	Tornier, Inc	0
2015-01-22	NAI	No action indicated	Tornier Inc.	0
2014-03-26	NAI	No action indicated	Tornier, Inc	0
2013-01-31	VAI	Voluntary action indicated	Tornier, Inc	4
2011-11-03	NAI	No action indicated	Tornier, Inc	0

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