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.
10 linked reportsMalfunction 8Injury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.25 |
| 2019-02 | 0 | 4.5 |
| 2019-03 | 0 | 1.5 |
| 2019-04 | 0 | 8 |
| 2019-05 | 0 | 2.67 |
| 2019-06 | 0 | 6 |
| 2019-07 | 0 | 3 |
| 2019-08 | 0 | 10.25 |
| 2019-09 | 0 | 23.5 |
| 2019-10 | 0 | 16.4 |
| 2019-11 | 0 | 36 |
| 2019-12 | 0 | 26.5 |
| 2020-01 | 0 | 23 |
| 2020-02 | 0 | 9.5 |
| 2020-03 | 0 | 10.33 |
| 2020-04 | 0 | 2.8 |
| 2020-05 | 0 | 15.5 |
| 2020-06 | 0 | 24 |
| 2020-07 | 1 | 3.17 |
| 2020-08 | 0 | 4.5 |
| 2020-09 | 0 | 7 |
| 2020-10 | 0 | 1.67 |
| 2020-11 | 0 | 14 |
| 2020-12 | 0 | 14 |
| 2021-01 | 0 | 3 |
| 2021-02 | 0 | 14 |
| 2021-03 | 0 | 19.67 |
| 2021-04 | 0 | 12 |
| 2021-05 | 0 | 18 |
| 2021-06 | 0 | 4 |
| 2021-07 | 0 | 20 |
| 2021-08 | 0 | 10 |
| 2021-09 | 0 | 4.5 |
| 2021-10 | 0 | 2.5 |
| 2021-11 | 0 | 3.5 |
| 2021-12 | 0 | 3 |
| 2022-01 | 0 | 1 |
| 2022-02 | 0 | 9.5 |
| 2022-03 | 0 | 2 |
| 2022-04 | 0 | 1.2 |
| 2022-05 | 0 | 2 |
| 2022-06 | 0 | 4 |
| 2022-07 | 0 | 2.75 |
| 2022-08 | 0 | 2 |
| 2022-09 | 0 | 1.25 |
| 2022-10 | 0 | 2.75 |
| 2022-11 | 0 | 1 |
| 2022-12 | 0 | 2.33 |
| 2023-01 | 0 | 1 |
| 2023-02 | 0 | 2 |
| 2023-04 | 1 | 1.67 |
| 2023-05 | 0 | 2 |
| 2023-06 | 2 | 2.25 |
| 2023-07 | 1 | 1.14 |
| 2023-08 | 0 | 5 |
| 2023-09 | 0 | 10 |
| 2023-10 | 0 | 1 |
| 2023-11 | 0 | 2 |
| 2023-12 | 0 | 1 |
| 2024-01 | 0 | 3.67 |
| 2024-02 | 0 | 2 |
| 2024-03 | 1 | 1.33 |
| 2024-04 | 0 | 1 |
| 2024-05 | 0 | 2 |
| 2024-06 | 0 | 3 |
| 2024-07 | 1 | 1 |
| 2024-09 | 0 | 2.5 |
| 2024-10 | 0 | 1.25 |
| 2024-11 | 0 | 5 |
| 2024-12 | 0 | 1 |
| 2025-01 | 1 | 1.17 |
| 2025-03 | 0 | 2 |
| 2025-04 | 0 | 1.33 |
| 2025-05 | 0 | 3 |
| 2025-06 | 0 | 2.67 |
| 2025-07 | 0 | 1 |
| 2025-08 | 0 | 1 |
| 2025-10 | 1 | 1 |
| 2025-12 | 0 | 1 |
| 2026-01 | 0 | 1 |
| 2026-02 | 1 | 2.67 |
| 2026-03 | 0 | 23.75 |
| 2026-04 | 0 | 55 |
| 2026-05 | 0 | 7.33 |
| 2026-06 | 0 | 1 |
Failure-mode summaryAI-generated
10 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2023-08-07 | Z-2600-2023 | Class II | Open, Classified | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical siteDistribution: Nationwide Foreign: Austria Belgium Canada France Germany Hong Kong Italy Malaysia Poland Singapore South Korea Spain Taiwan Thailand UK | 652 units US; 1607 units OUS | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-02-24 | 3015967359-2026-00130 | Malfunction | Available | exact di |
| 2025-10-30 | 3015967359-2025-01579 | Malfunction | Available | exact di |
| 2025-01-22 | 3015967359-2025-00327 | Malfunction | Available | exact di |
| 2024-07-26 | 3015967359-2024-01608 | Malfunction | Available | exact di |
| 2024-03-07 | 3015967359-2024-00466 | Malfunction | Available | exact di |
| 2023-07-26 | 3015967359-2023-01535 | Malfunction | Available | exact di |
| 2023-06-20 | 3015967359-2023-01328 | Injury | Available | exact di |
| 2023-06-02 | 3015967359-2023-01227 | Injury | Available | exact di |
| 2023-04-24 | 3015967359-2023-00826 | Malfunction | Available | exact di |
| 2020-07-27 | 0001811755-2020-01881 | Malfunction | Available | exact di |
Regulatory clearances
None linked.
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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