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Stryker Leibinger GmbH & Co. KG Recalls
25 recalls on record · February 15, 2017 to May 29, 2024 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 29, 2024Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls 8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution
Hazard: 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.
May 15, 2024Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony
Hazard: Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure
March 15, 2023Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Hazard: Device was shipped without having regulatory approval.
March 9, 2022Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
Hazard: 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.
April 28, 2021Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-
Hazard: Inability for the user to inject the paste from the syringe into the target location.
September 5, 2018Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium
Hazard: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
September 5, 2018Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01546S, for use on the
Hazard: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
September 5, 2018Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the
Hazard: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
September 5, 2018Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium
Hazard: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
September 5, 2018Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium
Hazard: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
September 5, 2018Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium
Hazard: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
September 5, 2018Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium
Hazard: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
September 5, 2018Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01536S, for use on t
Hazard: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
September 5, 2018Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, for use on t
Hazard: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
September 5, 2018Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01532S, for use on the cranium
Hazard: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
September 5, 2018Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium
Hazard: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
September 5, 2018Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium
Hazard: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
September 5, 2018Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on the cranium
Hazard: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
September 5, 2018Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S, for use on
Hazard: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
September 5, 2018Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on
Hazard: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
September 5, 2018Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium.
Hazard: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
September 5, 2018Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap St
Hazard: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
September 5, 2018Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap S
Hazard: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
February 15, 2017Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls 9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Ex
Hazard: An incorrect sterility status on the label, non-sterile products labeled as sterile
February 15, 2017Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile)
Hazard: An incorrect sterility status on the label, non-sterile products labeled as sterile