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Unnamed device
Model 5050 · STRYKER CORPORATION · DI 07613327282511
FPO — Stretcher, Wheeled · Class II · 21 CFR 880.6910
UDILibrary device dossier · generated 2026-09-12 · 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
2021-05-12
Z-2220-2021
Class II
Open, Classified
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the
correct use environment, but home users may not be aware of or fully understand these instructions
intended for healthcare professionals
code info di
Adverse-event reports — MAUDE (89)
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.
Malfunction: 89
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
4
2.41
2019-02
1
1.71
2019-03
0
3
2019-04
2
2.46
2019-05
0
1.89
2019-06
0
2.33
2019-07
2
2.48
2019-08
0
2
2019-09
0
1
2019-10
2
2.59
2019-11
0
1.8
2019-12
0
2.5
2020-01
4
2.8
2020-02
0
2.5
2020-03
0
1.17
2020-04
5
3
2020-05
0
2.8
2020-06
0
1.67
2020-07
2
2.92
2020-08
0
1.15
2020-09
0
1.5
2020-10
2
2.92
2020-11
0
2.25
2020-12
0
1
2021-01
4
4.96
2021-02
1
3.35
2021-03
0
1.67
2021-04
2
2.43
2021-05
0
2
2021-06
0
1.89
2021-07
2
2.47
2021-08
0
1.6
2021-09
0
1.2
2021-10
2
2.83
2021-11
0
1.17
2021-12
0
1.67
2022-01
1
2.72
2022-02
0
1
2022-03
0
1.75
2022-04
3
3.1
2022-05
0
2.33
2022-06
0
1
2022-07
6
3.23
2022-08
0
1.75
2022-09
0
4
2022-10
3
3.29
2022-11
0
1.43
2022-12
0
2
2023-01
5
3.16
2023-02
0
1.67
2023-03
0
2.3
2023-04
4
3.68
2023-05
0
2.33
2023-06
0
2.4
2023-07
2
3.68
2023-08
0
1.63
2023-09
0
1.77
2023-10
4
3.5
2023-11
0
2.5
2023-12
0
2.4
2024-01
3
3.57
2024-02
0
3.17
2024-03
0
1.71
2024-04
3
4.21
2024-05
0
1.43
2024-06
0
2.3
2024-07
2
3.51
2024-08
0
1.57
2024-09
0
7
2024-10
3
4
2024-11
0
5.43
2024-12
0
4.6
2025-01
2
3.77
2025-02
0
6.67
2025-03
0
8
2025-04
4
3.81
2025-05
0
6
2025-06
0
3
2025-07
1
3.23
2025-08
0
5.67
2025-09
0
5
2025-10
4
3.47
2025-11
0
5.67
2025-12
0
3.22
2026-01
2
3.13
2026-02
0
4.67
2026-03
1
5.11
2026-04
1
3.84
2026-05
0
10.43
2026-06
0
7.43
This device (reports/month)Average device in FPO (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
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