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Aliquot
Model 2090-0501 · Stryker Corporation · DI 00808232001020
KIH — Dispenser, Cement · Class I · 21 CFR 888.4200
OAR — Injector, Vertebroplasty (Does Not Contain Cement) · Class I · 21 CFR 888.4200
UDILibrary device dossier · generated 2026-09-14 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.
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
2.2
2019-02
0
8
2019-03
0
2.33
2019-04
0
4.29
2019-05
0
2.33
2019-06
0
6
2019-07
0
2.83
2019-08
0
19.5
2019-09
0
16.67
2019-10
0
16.4
2019-11
0
36
2019-12
0
26.5
2020-01
0
17.75
2020-02
0
5.5
2020-03
0
10
2020-04
0
3
2020-05
0
2
2020-06
0
8.33
2020-07
0
2.44
2020-08
0
3
2020-09
0
4
2020-10
0
1.75
2020-11
0
7.5
2020-12
0
7.5
2021-01
0
2.5
2021-02
0
14
2021-03
0
13
2021-04
0
7.17
2021-05
0
18
2021-06
0
3.5
2021-07
0
4.33
2021-08
0
10
2021-09
0
3.33
2021-10
0
1.75
2021-11
0
2.2
2021-12
0
4.5
2022-01
0
1.5
2022-02
0
1.33
2022-03
0
1.33
2022-04
0
1.67
2022-05
0
2
2022-06
0
3
2022-07
0
2.67
2022-08
0
1.33
2022-09
0
1
2022-10
0
2.5
2022-11
0
1
2022-12
0
2
2023-01
0
1.33
2023-02
0
2
2023-03
0
2
2023-04
0
1.13
2023-05
0
2
2023-06
0
2.25
2023-07
0
1.33
2023-08
0
1.67
2023-09
0
2.67
2023-10
0
1
2023-11
0
3.33
2023-12
0
1
2024-01
0
3.67
2024-02
0
2
2024-03
0
2.67
2024-04
0
1
2024-05
0
1.4
2024-06
0
1
2024-07
0
1
2024-08
0
1.25
2024-09
0
2
2024-10
0
1.14
2024-11
0
3.4
2024-12
0
8
2025-01
0
1.33
2025-02
0
1
2025-03
0
2.43
2025-04
0
1.44
2025-05
0
3
2025-06
0
2.89
2025-07
0
1.33
2025-08
0
8.5
2025-09
0
2
2025-10
0
2.89
2025-11
0
10.5
2025-12
0
3.5
2026-01
0
1.17
2026-02
0
1.5
2026-03
0
2.8
2026-04
0
1.14
2026-05
0
1.6
2026-06
0
1.33
This device (reports/month)Average device in KIH, OAR (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Stryker Corporation
Warning Letter 2017-04-06 Entellus Medical Inc.
Warning Letter 2015-04-08 Thermedx LLC
Injunction 2013-11-26 Physio-Control, Inc.
Warning Letter 2013-03-06 Stryker Corporation
Warning Letter 2013-03-06 Stryker Corporation
NAI 2026-06-18 International Life Sciences · 0 citations
VAI 2026-02-20 Stryker Puerto Rico, LLC · 2 citations
NAI 2025-12-11 Stryker Manufacturing Kalamazoo · 0 citations
NAI 2025-05-22 Stryker Macroom · 0 citations
VAI 2025-03-27 Stryker GmbH · 1 citations
VAI 2025-03-27 Stryker GmbH · 1 citations
NAI 2025-02-27 Stryker Leibinger GmbH & Co. KG · 0 citations
NAI 2025-01-30 Serf · 0 citations
VAI 2024-12-18 Stryker Neurovascular · 1 citations
VAI 2024-11-15 Stryker Medical Division of Stryker Corporation · 2 citations
NAI 2024-11-13 POM Medical LLC · 0 citations
VAI 2024-07-25 Stryker Ireland, Ltd., Instruments Division · 1 citations
NAI 2024-05-03 Stryker Neurovascular, Inc. · 0 citations
NAI 2024-04-18 Physio-Control, Inc. · 0 citations
VAI 2023-12-01 Howmedica Osteonics Corp. · 1 citations
VAI 2023-05-15 LimFlow, Inc. · 2 citations
NAI 2023-04-25 Stryker Puerto Rico, LLC · 0 citations