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.
112 linked reportsMalfunction 100Injury 12
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 1 | 4.67 |
| 2019-02 | 1 | 2.34 |
| 2019-03 | 0 | 3.13 |
| 2019-04 | 1 | 3.17 |
| 2019-05 | 1 | 3.26 |
| 2019-06 | 0 | 2.82 |
| 2019-07 | 1 | 3.81 |
| 2019-08 | 0 | 3.49 |
| 2019-09 | 0 | 3.35 |
| 2019-10 | 0 | 3.19 |
| 2019-11 | 0 | 5.28 |
| 2019-12 | 2 | 5.45 |
| 2020-01 | 3 | 5.46 |
| 2020-02 | 1 | 4.5 |
| 2020-03 | 0 | 3.98 |
| 2020-04 | 0 | 5.42 |
| 2020-05 | 0 | 3.88 |
| 2020-06 | 1 | 3.71 |
| 2020-07 | 0 | 3.74 |
| 2020-08 | 0 | 4.23 |
| 2020-09 | 0 | 4.05 |
| 2020-10 | 1 | 4.53 |
| 2020-11 | 0 | 6.39 |
| 2020-12 | 0 | 5.41 |
| 2021-01 | 0 | 4.74 |
| 2021-02 | 3 | 3.95 |
| 2021-03 | 3 | 3.83 |
| 2021-04 | 0 | 3.82 |
| 2021-05 | 2 | 4.06 |
| 2021-06 | 4 | 4.11 |
| 2021-07 | 0 | 4 |
| 2021-08 | 1 | 4.46 |
| 2021-09 | 0 | 4.05 |
| 2021-10 | 2 | 4.44 |
| 2021-11 | 1 | 4.37 |
| 2021-12 | 0 | 4.43 |
| 2022-01 | 0 | 4 |
| 2022-02 | 0 | 3.37 |
| 2022-03 | 0 | 3.88 |
| 2022-04 | 0 | 3.8 |
| 2022-05 | 0 | 4.06 |
| 2022-06 | 0 | 3.85 |
| 2022-07 | 0 | 3.56 |
| 2022-08 | 0 | 4.39 |
| 2022-09 | 0 | 3.86 |
| 2022-10 | 2 | 4.15 |
| 2022-11 | 0 | 2.87 |
| 2022-12 | 1 | 3.93 |
| 2023-01 | 0 | 3.27 |
| 2023-02 | 0 | 3.2 |
| 2023-03 | 0 | 3.8 |
| 2023-04 | 2 | 4.26 |
| 2023-05 | 25 | 4.67 |
| 2023-06 | 0 | 4.2 |
| 2023-07 | 1 | 3.85 |
| 2023-08 | 2 | 4.49 |
| 2023-09 | 2 | 4.47 |
| 2023-10 | 0 | 4.71 |
| 2023-11 | 3 | 4.63 |
| 2023-12 | 0 | 5.49 |
| 2024-01 | 0 | 5.56 |
| 2024-02 | 0 | 4.93 |
| 2024-03 | 0 | 4.78 |
| 2024-04 | 0 | 5.43 |
| 2024-05 | 0 | 6.48 |
| 2024-06 | 0 | 7.52 |
| 2024-07 | 0 | 4.11 |
| 2024-08 | 0 | 4.21 |
| 2024-09 | 1 | 5 |
| 2024-10 | 1 | 4.7 |
| 2024-11 | 1 | 4.41 |
| 2024-12 | 4 | 4.25 |
| 2025-01 | 0 | 5.12 |
| 2025-02 | 2 | 4.81 |
| 2025-03 | 13 | 4.57 |
| 2025-04 | 13 | 4.98 |
| 2025-05 | 0 | 5.81 |
| 2025-06 | 1 | 5.47 |
| 2025-07 | 1 | 5.19 |
| 2025-08 | 0 | 5.08 |
| 2025-09 | 2 | 4.29 |
| 2025-10 | 1 | 4.62 |
| 2025-11 | 0 | 5.25 |
| 2025-12 | 1 | 6.07 |
| 2026-01 | 0 | 5.06 |
| 2026-02 | 0 | 5.39 |
| 2026-03 | 1 | 5.98 |
| 2026-04 | 0 | 5.93 |
| 2026-05 | 1 | 5.88 |
| 2026-06 | 2 | 6.16 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2023-08-23 | Z-2645-2023 | Class II | Open, Classified | Expired Product distributedDistribution: US Nationwide distribution in the states of NY, NC, GA, TN, KY, IL, UT, AZ, NM, CA. | 96 units | clearance family |
| 2016-04-12 | Z-1634-2016 | Class II | Terminated | Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of s of an internal wire breaking upon deployment of the anchor.Distribution: Distributed US (nationwide) and in Australia, Switzerland, Netherlands, Spain and Sweden. | 3100 total device, both model numbers. | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-19 | 0002936485-2026-00395 | Injury | Available | exact di |
| 2026-06-08 | 0002936485-2026-00366 | Injury | Available | exact di |
| 2026-05-11 | 0002936485-2026-00288 | Malfunction | Available | exact di |
| 2026-03-06 | 0002936485-2026-00145 | Malfunction | Available | exact di |
| 2025-12-12 | 0002936485-2025-00986 | Malfunction | Available | exact di |
| 2025-10-23 | 0002936485-2025-00868 | Malfunction | Available | exact di |
| 2025-09-25 | 0002936485-2025-00801 | Malfunction | Available | exact di |
| 2025-09-23 | 0002936485-2025-00794 | Malfunction | Available | exact di |
| 2025-07-15 | 0002936485-2025-00638 | Malfunction | Available | exact di |
| 2025-06-06 | 0002936485-2025-00522 | Malfunction | Available | exact di |
| 2025-04-25 | 0002936485-2025-00383 | Malfunction | Available | exact di |
| 2025-04-25 | 0002936485-2025-00389 | Malfunction | Available | exact di |
| 2025-04-25 | 0002936485-2025-00391 | Malfunction | Available | exact di |
| 2025-04-22 | 0002936485-2025-00364 | Malfunction | Available | exact di |
| 2025-04-22 | 0002936485-2025-00371 | Malfunction | Available | exact di |
Showing 1–15 of 112
Regulatory clearances
- 510(k)K131769Substantially equivalent (SESE) · 2013-10-07clearance family
Predicate lineage
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 |
|---|---|---|---|---|
| 2026-06-18 | NAI | No action indicated | International Life Sciences | 0 |
| 2026-02-20 | VAI | Voluntary action indicated | Stryker Puerto Rico, LLC | 2 |
| 2025-12-11 | NAI | No action indicated | Stryker Manufacturing Kalamazoo | 0 |
| 2025-05-22 | NAI | No action indicated | Stryker Macroom | 0 |
| 2025-03-27 | VAI | Voluntary action indicated | Stryker GmbH | 1 |
| 2025-03-27 | VAI | Voluntary action indicated | Stryker GmbH | 1 |
| 2025-02-27 | NAI | No action indicated | Stryker Leibinger GmbH & Co. KG | 0 |
| 2025-01-30 | NAI | No action indicated | Serf | 0 |
| 2024-12-18 | VAI | Voluntary action indicated | Stryker Neurovascular | 1 |
| 2024-11-15 | VAI | Voluntary action indicated | Stryker Medical Division of Stryker Corporation | 2 |
| 2024-11-13 | NAI | No action indicated | POM Medical LLC | 0 |
| 2024-07-25 | VAI | Voluntary action indicated | Stryker Ireland, Ltd., Instruments Division | 1 |
| 2024-05-03 | NAI | No action indicated | Stryker Neurovascular, Inc. | 0 |
| 2024-04-18 | NAI | No action indicated | Physio-Control, Inc. | 0 |
| 2023-12-01 | VAI | Voluntary action indicated | Howmedica Osteonics Corp. | 1 |
| 2023-05-15 | VAI | Voluntary action indicated | LimFlow, Inc. | 2 |
| 2023-04-25 | NAI | No action indicated | Stryker Puerto Rico, LLC | 0 |
| 2023-01-24 | VAI | Voluntary action indicated | Stryker Corporation | 2 |
| 2023-01-24 | VAI | Voluntary action indicated | Stryker Corporation | 2 |
| 2022-03-08 | VAI | Voluntary action indicated | POM Medical LLC | 0 |
| 2017-04-06 | WL | Warning Letter | Entellus Medical Inc. | — |
| 2015-04-08 | WL | Warning Letter | Thermedx LLC | — |
| 2013-11-26 | INJ | Injunction | Physio-Control, Inc. | — |
| 2013-03-06 | WL | Warning Letter | Stryker Corporation | — |
| 2013-03-06 | WL | Warning Letter | Stryker Corporation | — |
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