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ACM
Model 0306564000 · STRYKER CORPORATION · DI 04546540899071
JDZ — Mixer, Cement, For Clinical Use · Class I · 21 CFR 888.4210
UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2023-08-07
Z-2599-2023
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 site
code info di
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
2.25
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
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
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
0
1.67
2023-05
0
2
2023-06
0
2.25
2023-07
0
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
0
1.33
2024-04
0
1
2024-05
0
2
2024-06
0
3
2024-07
0
1
2024-09
0
2.5
2024-10
0
1.25
2024-11
0
5
2024-12
0
1
2025-01
0
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
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
This device (reports/month)Average device in JDZ (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