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.
44 linked reportsMalfunction 41Injury 3
| 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 | 1 | 8 |
| 2019-05 | 1 | 2.67 |
| 2019-06 | 0 | 6 |
| 2019-07 | 1 | 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 | 1 | 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 | 0 | 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 | 1 | 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 | 1 | 1.2 |
| 2022-05 | 0 | 2 |
| 2022-06 | 0 | 4 |
| 2022-07 | 1 | 2.75 |
| 2022-08 | 0 | 2 |
| 2022-09 | 2 | 1.25 |
| 2022-10 | 0 | 2.75 |
| 2022-11 | 1 | 1 |
| 2022-12 | 0 | 2.33 |
| 2023-01 | 1 | 1 |
| 2023-02 | 0 | 2 |
| 2023-04 | 4 | 1.67 |
| 2023-05 | 0 | 2 |
| 2023-06 | 2 | 2.25 |
| 2023-07 | 2 | 1.14 |
| 2023-08 | 14 | 5 |
| 2023-09 | 1 | 10 |
| 2023-10 | 1 | 1 |
| 2023-11 | 0 | 2 |
| 2023-12 | 1 | 1 |
| 2024-01 | 1 | 3.67 |
| 2024-02 | 0 | 2 |
| 2024-03 | 0 | 1.33 |
| 2024-04 | 1 | 1 |
| 2024-05 | 0 | 2 |
| 2024-06 | 0 | 3 |
| 2024-07 | 1 | 1 |
| 2024-09 | 0 | 2.5 |
| 2024-10 | 1 | 1.25 |
| 2024-11 | 0 | 5 |
| 2024-12 | 0 | 1 |
| 2025-01 | 1 | 1.17 |
| 2025-03 | 1 | 2 |
| 2025-04 | 1 | 1.33 |
| 2025-05 | 0 | 3 |
| 2025-06 | 0 | 2.67 |
| 2025-07 | 0 | 1 |
| 2025-08 | 1 | 1 |
| 2025-10 | 0 | 1 |
| 2025-12 | 0 | 1 |
| 2026-01 | 0 | 1 |
| 2026-02 | 0 | 2.67 |
| 2026-03 | 0 | 23.75 |
| 2026-04 | 0 | 55 |
| 2026-05 | 0 | 7.33 |
| 2026-06 | 0 | 1 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2023-08-07 | Z-2598-2023 | 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 | 5155 units US; 1607 units OUS | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-08-12 | 3015967359-2025-01364 | Malfunction | Available | exact di |
| 2025-04-21 | 3015967359-2025-00914 | Malfunction | Available | exact di |
| 2025-03-31 | 3015967359-2025-00582 | Malfunction | Available | exact di |
| 2025-01-21 | 3015967359-2025-00059 | Malfunction | Available | exact di |
| 2024-10-22 | 3015967359-2024-02213 | Malfunction | Available | exact di |
| 2024-07-24 | 3015967359-2024-01484 | Malfunction | Available | exact di |
| 2024-04-15 | 3015967359-2024-00733 | Malfunction | Available | exact di |
| 2024-01-22 | 3015967359-2024-00171 | Malfunction | Available | exact di |
| 2023-12-20 | 3015967359-2023-02644 | Malfunction | Available | exact di |
| 2023-10-23 | 3015967359-2023-02222 | Malfunction | Available | exact di |
| 2023-09-13 | 3015967359-2023-01951 | Malfunction | Available | exact di |
| 2023-08-31 | 3015967359-2023-01922 | Malfunction | Available | exact di |
| 2023-08-11 | 3015967359-2023-01816 | Malfunction | Available | exact di |
| 2023-08-11 | 3015967359-2023-01817 | Malfunction | Available | exact di |
| 2023-08-11 | 3015967359-2023-01818 | Malfunction | Available | exact di |
Showing the most recent 43 of 44 linked reports.
Showing 1–15 of 43
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 | — |
Similar devices
- MiniMix™ SUMMIT MEDICAL LIMITED
- 2Mix TECRES SPA
- Arthrex Bone Cement Closed Mixing Bowl G21 SRL
- Arthrex Bone Cement Closed Mixing Bowl G21 SRL
- Arthrex Bone Cement Mixing Syringe G21 SRL
- Arthrex Bone Cement Mixing Syringe G21 SRL
- Arthrex Bone Cement Open Mixing Bowl G21 SRL
- BIOPSYBELL BIOPSYBELL SRL
- BOWL AND SPATULA TECRES SPA
- CLEANEST Guangzhou Clean Medical Products Manufacturing Corp.
- CLEANEST Guangzhou Clean Medical Products Manufacturing Corp.
- CLEANEST Guangzhou Clean Medical Products Manufacturing Corp.
Select up to two to place side-by-side with this device.