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Leforte Neuro System Bone Plate

Jeil Medical Corporation · Model N16-TM-010S · UDI-DI 08809265156253

GWO GXR HBW Prescription

510(k) clearances

944

Adverse events

Recalls

Facilities

Recalls

Date	Firm	Reason
2024-03-29	Stryker Leibinger GmbH & Co. KG	Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure
2023-05-31	Osteomed, LLC	Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
2023-05-31	Osteomed, LLC	Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
2018-06-22	Stryker Leibinger GmbH & Co. KG	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
2018-06-22	Stryker Leibinger GmbH & Co. KG	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
2018-06-22	Stryker Leibinger GmbH & Co. KG	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
2018-06-22	Stryker Leibinger GmbH & Co. KG	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
2018-06-22	Stryker Leibinger GmbH & Co. KG	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
2018-06-22	Stryker Leibinger GmbH & Co. KG	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
2018-06-22	Stryker Leibinger GmbH & Co. KG	After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.