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Scopis
Model 8000-021-002 · Stryker Leibinger GmbH & Co. KG · DI 07613327514179
PGW — Ear, Nose, And Throat Stereotaxic Instrument · Class II · 21 CFR 882.4560
UDILibrary device dossier · generated 2026-09-06 · 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
2024-04-04
Z-1885-2024
Class II
Open, Classified
Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference point of the pointer or suction.
code info di
Adverse-event reports — MAUDE (20)
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: 20
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
2.75
2019-02
0
3
2019-03
0
4.67
2019-04
0
2.44
2019-05
0
22
2019-06
0
4.25
2019-07
0
6
2019-08
0
7
2019-09
0
2.2
2019-10
0
1.75
2019-11
0
1.25
2019-12
0
5
2020-01
0
1.5
2020-02
0
2.4
2020-03
0
6
2020-04
0
1.5
2020-05
0
2
2020-06
0
2.4
2020-07
0
3
2020-08
0
5
2020-09
0
1.33
2020-10
0
6
2020-11
0
1.5
2020-12
0
5
2021-01
0
3
2021-02
0
4.5
2021-03
0
8
2021-04
0
5.33
2021-05
0
10.5
2021-06
0
5
2021-07
0
6.67
2021-08
0
5.6
2021-09
0
3.2
2021-10
0
3
2021-11
0
3
2021-12
0
3.67
2022-01
0
2.5
2022-02
0
3.75
2022-03
0
4.5
2022-04
0
3
2022-05
0
4.5
2022-06
0
2.89
2022-07
0
3.75
2022-08
0
3
2022-09
0
2.33
2022-10
0
5.5
2022-11
0
5.2
2022-12
0
2.25
2023-01
0
4.83
2023-02
0
2.67
2023-03
0
3.11
2023-04
0
3.5
2023-05
0
5.17
2023-06
2
3
2023-07
0
3.5
2023-08
0
3.8
2023-09
0
2.89
2023-10
5
2.5
2023-11
3
2.89
2023-12
0
4.11
2024-01
0
2
2024-02
2
3.25
2024-03
0
2.7
2024-04
0
4.09
2024-05
0
2.73
2024-06
0
2.33
2024-07
1
3
2024-08
0
6.67
2024-09
0
2
2024-10
1
4.6
2024-11
0
4.83
2024-12
0
3.8
2025-01
1
1.92
2025-02
0
4.65
2025-03
0
3.43
2025-04
1
1.93
2025-05
0
5.67
2025-06
0
8.5
2025-07
1
1.75
2025-08
0
4
2025-09
0
3
2025-10
1
2.4
2025-11
0
4.5
2025-12
0
2
2026-01
1
2.1
2026-02
0
2.33
2026-03
0
6.5
2026-04
1
1.38
2026-05
0
3
2026-06
0
2
This device (reports/month)Average device in PGW (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Stryker Leibinger GmbH & Co. KG
NAI 2025-02-27 Stryker Leibinger GmbH & Co. KG · 0 citations
NAI 2017-07-27 Stryker Leibinger GmbH & Co. KG · 0 citations
NAI 2013-11-14 Stryker Leibinger GmbH & Co. KG · 0 citations