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.

92 linked reportsInjury 92

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	0	2.04
2022-02	1	2.04
2022-03	1	1.73
2022-04	0	2.04
2022-05	0	1.88
2022-06	0	2.01
2022-07	0	2.05
2022-08	0	2
2022-09	3	1.84
2022-10	0	1.87
2022-11	1	2.02
2022-12	1	1.82
2023-01	3	1.72
2023-02	3	1.94
2023-03	0	1.93
2023-04	3	1.92
2023-05	1	2
2023-06	3	2.26
2023-07	0	2.07
2023-08	4	1.67
2023-09	3	1.51
2023-10	2	1.56
2023-11	0	1.61
2023-12	0	1.41
2024-01	0	1.99
2024-02	0	1.76
2024-03	3	1.68
2024-04	1	1.77
2024-05	2	1.72
2024-06	2	1.9
2024-07	2	1.6
2024-08	4	1.7
2024-09	1	1.71
2024-10	0	1.61
2024-11	1	1.58
2024-12	0	1.63
2025-01	2	1.72
2025-02	1	1.56
2025-03	3	1.84
2025-04	3	1.63
2025-05	1	1.75
2025-06	2	1.83
2025-07	2	1.71
2025-08	2	1.53
2025-09	2	1.51
2025-10	3	1.62
2025-11	0	1.71
2025-12	3	2.11
2026-01	8	1.87
2026-02	3	1.8
2026-03	4	1.75
2026-04	4	1.7
2026-05	1	1.75
2026-06	3	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
2026-06-16	3000931034-2026-00509	Injury	Available	exact di
2026-06-09	3000931034-2026-00493	Injury	Available	exact di
2026-06-08	3000931034-2026-00487	Injury	Available	exact di
2026-05-15	3000931034-2026-00405	Injury	Available	exact di
2026-04-30	3000931034-2026-00390	Injury	Available	exact di
2026-04-29	3000931034-2026-00380	Injury	Available	exact di
2026-04-28	3000931034-2026-00374	Injury	Available	exact di
2026-04-14	3000931034-2026-00345	Injury	Available	exact di
2026-03-10	3000931034-2026-00252	Injury	Available	exact di
2026-03-05	3000931034-2026-00243	Injury	Available	exact di
2026-03-03	3000931034-2026-00229	Injury	Available	exact di
2026-03-03	3000931034-2026-00228	Injury	Available	exact di
2026-02-16	3000931034-2026-00191	Injury	Available	exact di
2026-02-16	3000931034-2026-00171	Injury	Available	exact di
2026-02-12	3000931034-2026-00143	Injury	Available	exact di

Showing the most recent 84 of 92 linked reports.

Showing 1–15 of 84

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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