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Stryker Leibinger GmbH & Co. KG FDA Recalls

5 recalls on file across devices, 0 of them Class I and 3 still open. Matched by name to SYK.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solutionClass IIApr 4, 2024Unreleased software was installed on customer systems result	Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show t	Class IIDevices	Apr 4, 2024
Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bonyClass IIMar 29, 2024Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was	Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a d	Class IIDevices	Mar 29, 2024
Patient-Fitted Temporomandibular (TMJ) Reconstruction ProsthesisClass IIDec 6, 2022Device was shipped without having regulatory approval.	Device was shipped without having regulatory approval.	Class IIDevices	Dec 6, 2022
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032Class IIDec 29, 2021Inside the packaging of one reported item a non-conforming p	Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barr	Class IIDevices	Dec 29, 2021
DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Class IIApr 1, 2021Inability for the user to inject the paste from the syringe	Inability for the user to inject the paste from the syringe into the target location.	Class IIDevices	Apr 1, 2021

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