Stryker Leibinger Gmbh & Co. Kg

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.

Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure

Device was shipped without having regulatory approval.

An incorrect sterility status on the label, non-sterile products labeled as sterile

An incorrect sterility status on the label, non-sterile products labeled as sterile

Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.

Inability for the user to inject the paste from the syringe into the target location.

After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.