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Unnamed device

Model 12-01534S · Stryker Leibinger GmbH & Co. KG · DI 07613252288213

GWO — Plate, Cranioplasty, Preformed, Alterable · Class II · 21 CFR 882.5320

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 (18)

Initiated	Recall #	Class	Status	Reason	Link basis
2018-06-22	Z-2898-2018	Class II	Terminated	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.	k number procode
2018-06-22	Z-2899-2018	Class II	Terminated	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.	k number procode
2018-06-22	Z-2900-2018	Class II	Terminated	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.	k number procode
2018-06-22	Z-2901-2018	Class II	Terminated	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.	k number procode
2018-06-22	Z-2902-2018	Class II	Terminated	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.	k number procode
2018-06-22	Z-2903-2018	Class II	Terminated	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.	k number procode
2018-06-22	Z-2904-2018	Class II	Terminated	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.	k number procode
2018-06-22	Z-2905-2018	Class II	Terminated	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.	k number procode
2018-06-22	Z-2906-2018	Class II	Terminated	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.	k number procode
2018-06-22	Z-2907-2018	Class II	Terminated	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.	k number procode
2018-06-22	Z-2908-2018	Class II	Terminated	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.	k number procode
2018-06-22	Z-2909-2018	Class II	Terminated	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.	k number procode
2018-06-22	Z-2910-2018	Class II	Terminated	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.	k number procode
2018-06-22	Z-2911-2018	Class II	Terminated	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.	k number procode
2018-06-22	Z-2912-2018	Class II	Terminated	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.	k number procode
2018-06-22	Z-2913-2018	Class II	Terminated	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.	k number procode
2018-06-22	Z-2914-2018	Class II	Terminated	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.	k number procode
2018-06-22	Z-2915-2018	Class II	Terminated	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.	k number procode

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	1.5
2019-02	0	1
2019-03	0	2.71
2019-04	0	1.5
2019-05	0	2
2019-06	0	1.25
2019-07	0	1.67
2019-08	0	2
2019-09	0	1.5
2019-12	0	12
2020-01	0	2.14
2020-02	0	1.64
2020-03	0	2.75
2020-04	0	1.6
2020-05	0	2.57
2020-06	0	2.5
2020-07	0	3
2020-08	0	1.86
2020-09	0	4
2020-10	0	1.9
2020-11	0	2
2020-12	0	3
2021-01	0	1
2021-02	0	1
2021-03	0	1.75
2021-04	0	5
2021-05	0	1.33
2021-06	0	1.75
2021-07	0	1.2
2021-08	0	2.5
2021-09	0	1.67
2021-10	0	2.71
2021-11	0	1.5
2021-12	0	1.38
2022-01	0	2.25
2022-02	0	4.4
2022-03	0	3.5
2022-04	0	1
2022-05	0	1.4
2022-06	0	6.4
2022-07	0	2
2022-08	0	1.6
2022-09	0	1.25
2022-10	0	2
2022-11	0	3.25
2022-12	0	4.1
2023-01	0	1.67
2023-02	0	2
2023-03	0	4
2023-04	0	14.2
2023-05	0	1.67
2023-06	0	6.5
2023-07	0	2
2023-08	0	1.25
2023-09	0	1.75
2023-10	0	3.5
2023-11	0	1
2023-12	0	1.5
2024-01	0	5.5
2024-02	0	2.75
2024-03	0	1.75
2024-04	0	2.55
2024-05	0	2
2024-06	0	1.75
2024-07	0	1
2024-08	0	1.2
2024-09	0	6
2024-10	0	4.33
2024-11	0	3.5
2024-12	0	1.33
2025-01	0	1.83
2025-02	0	1
2025-03	0	1.33
2025-04	0	1.64
2025-05	0	2.5
2025-06	0	2
2025-07	0	3.5
2025-09	0	1
2025-10	0	1.17
2025-11	0	1
2025-12	0	2.8
2026-01	0	1.86
2026-02	0	1
2026-03	0	4.5
2026-04	0	10
2026-05	0	2.33
2026-06	0	3.4

This device (reports/month)Average device in GWO (reports/device/month)

Regulatory clearances

K120352 SESE 2012-06-11 (k number procode)

Predicate lineage

K120352 — cited as predicate by K140309, K171152

Lineage extracted from public 510(k) summary text (heuristic).

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