DJO SURGICAL · 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.

21 linked reportsInjury 21

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	1.52
2019-02	0	1.36
2019-03	2	1.44
2019-04	0	1.37
2019-05	0	1.6
2019-06	0	1.13
2019-07	0	1.34
2019-08	0	1.35
2019-09	2	1.47
2019-10	2	1.46
2019-11	0	1.39
2019-12	0	1.52
2020-01	0	1.45
2020-02	0	1.7
2020-03	0	1.52
2020-04	0	1.42
2020-05	0	1.43
2020-06	0	1.43
2020-07	0	1.55
2020-08	0	1.33
2020-09	0	1.45
2020-10	0	1.55
2020-11	2	1.49
2020-12	0	1.57
2021-01	0	1.59
2021-02	2	1.42
2021-03	0	1.56
2021-04	2	1.44
2021-05	2	1.55
2021-06	2	1.65
2021-07	0	1.45
2021-08	0	1.5
2021-09	0	1.43
2021-10	0	1.57
2021-11	0	1.32
2021-12	2	1.31
2022-01	0	1.4
2022-02	0	1.3
2022-03	0	1.48
2022-04	0	1.37
2022-05	0	1.5
2022-06	0	1.39
2022-07	0	1.33
2022-08	0	1.34
2022-09	0	1.4
2022-10	2	1.37
2022-11	0	1.38
2022-12	0	1.43
2023-01	0	1.37
2023-02	0	1.33
2023-03	0	1.38
2023-04	0	1.42
2023-05	0	1.34
2023-06	0	1.23
2023-07	0	1.32
2023-08	0	1.3
2023-09	0	1.23
2023-10	0	1.18
2023-11	0	1.26
2023-12	0	1.21
2024-01	0	1.26
2024-02	0	1.28
2024-03	0	1.41
2024-04	0	1.15
2024-05	0	1.2
2024-06	0	1.29
2024-07	0	1.32
2024-08	0	1.19
2024-09	0	1.15
2024-10	0	1.24
2024-11	0	1.31
2024-12	0	1.19
2025-01	0	1.34
2025-02	0	1.25
2025-03	0	1.65
2025-04	0	1.57
2025-05	0	1.32
2025-06	0	1.56
2025-07	0	1.59
2025-08	0	1.23
2025-09	0	1.39
2025-10	0	1.46
2025-11	0	1.39
2025-12	0	1.56
2026-01	1	1.64
2026-02	0	1.24
2026-03	0	1.45
2026-04	0	1.6
2026-05	0	1.11
2026-06	0	1.37

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-01-26	1644408-2026-00128	Injury	Available	exact di
2022-10-13	1644408-2022-01334	Injury	Available	exact di
2021-12-22	1644408-2021-01461	Injury	Available	exact di
2021-06-29	1644408-2021-00656	Injury	Available	exact di
2021-05-20	1644408-2021-00449	Injury	Available	exact di
2021-04-09	1644408-2021-00232	Injury	Available	exact di
2021-02-16	1644408-2021-00086	Injury	Available	exact di
2020-11-22	1644408-2020-01127	Injury	Available	exact di
2019-10-03	1644408-2019-00951	Injury	Available	exact di
2019-09-12	1644408-2019-00863	Injury	Available	exact di
2019-03-29	1644408-2019-00237	Injury	Available	exact di

Showing the most recent 11 of 21 linked reports.

Regulatory clearances

Predicate lineage

K023794

Cited as predicate by: K112158, K191708

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2021-10-28	VAI	Voluntary action indicated	Encore Medical, LP	2
2020-03-11	NAI	No action indicated	Encore Medical, LP	0
2015-07-24	NAI	No action indicated	Encore Medical, LP	0
2013-06-28	VAI	Voluntary action indicated	Encore Medical, LP	2

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