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Stryker Leibinger GmbH & Co. KG: 25 FDA recall reports

Every medical device recall the FDA has published for Stryker Leibinger GmbH & Co. KG. The fault, and how the agency graded it.

25Reports

0Class I

3Ongoing

2024-05-29Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	25

By year reported

Year	Reports
2017	2
2018	18
2021	1
2022	1
2023	1
2024	2

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generatio

Z-1885-2024 · Class II · reported 2024-05-29 · Ongoing

Why it was recalled: 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.
Product: 8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. The Stryker Electromagnetic Navigation Unit (8000-010-003) powered by Scopis ENT Software with TGS (8000-021-002), allows the analysis and identification of sinus cells in the complex patient anatomy and planning of the natural drainage pathways through the sinus cavity. During surgery, the planned pathways are overlaid in real-time onto the endoscopic image, providing a unique Scopis augmented reality technology. Guidance of endoscopic instruments may help perform a minimally invasive, accurate and selective surgery.
Where it went: US Nationwide distribution.
How much: 705 units

Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation o

Z-1785-2024 · Class II · reported 2024-05-15 · Ongoing

Why it was recalled: Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure
Product: Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614
Where it went: Nationwide
How much: 63 units

Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis

Z-1234-2023 · Class II · reported 2023-03-15 · Ongoing

Why it was recalled: Device was shipped without having regulatory approval.
Product: Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Where it went: Distribution of one unit only to a single customer in MA (USA)
How much: 1 unit

MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032

Z-0715-2022 · Class II · reported 2022-03-09 · Terminated

Why it was recalled: 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.
Product: MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
Where it went: Worldwide distribution - US Nationwide.
How much: 74

DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through

Z-1436-2021 · Class II · reported 2021-04-28 · Terminated

Why it was recalled: Inability for the user to inject the paste from the syringe into the target location.
Product: DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite.
Where it went: Worldwide distribution - US Nationwide distribution and the countries of Germany, Italy, France, Australia, Japan.
How much: 321 units

AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the

Z-2910-2018 · Class II · reported 2018-09-05 · Terminated

Why it was recalled: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Product: AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium
Where it went: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
How much: 22,831 total

QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S,

Z-2902-2018 · Class II · reported 2018-09-05 · Terminated

Why it was recalled: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Product: QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S, for use on the cranium
Where it went: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
How much: 22,831 total

QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, f

Z-2901-2018 · Class II · reported 2018-09-05 · Terminated

Why it was recalled: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Product: QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium
Where it went: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
How much: 22,831 total

AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the crani

Z-2912-2018 · Class II · reported 2018-09-05 · Terminated

Why it was recalled: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Product: AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium
Where it went: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
How much: 22,831 total

QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker Qu

Z-2899-2018 · Class II · reported 2018-09-05 · Terminated

Why it was recalled: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Product: QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
Where it went: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
How much: 22,831 total

AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium

Z-2915-2018 · Class II · reported 2018-09-05 · Terminated

Why it was recalled: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Product: AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium
Where it went: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
How much: 22,831 total

QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cran

Z-2900-2018 · Class II · reported 2018-09-05 · Terminated

Why it was recalled: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Product: QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium.
Where it went: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
How much: 22,831 total

AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cr

Z-2911-2018 · Class II · reported 2018-09-05 · Terminated

Why it was recalled: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Product: AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium
Where it went: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
How much: 22,831 total

AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for

Z-2913-2018 · Class II · reported 2018-09-05 · Terminated

Why it was recalled: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Product: AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the cranium
Where it went: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
How much: 22,831 total

QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, fo

Z-2907-2018 · Class II · reported 2018-09-05 · Terminated

Why it was recalled: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Product: QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, for use on the cranium
Where it went: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
How much: 22,831 total

QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on the craniu

Z-2903-2018 · Class II · reported 2018-09-05 · Terminated

Why it was recalled: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Product: QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on the cranium
Where it went: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
How much: 22,831 total

AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01546S, for

Z-2914-2018 · Class II · reported 2018-09-05 · Terminated

Why it was recalled: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Product: AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01546S, for use on the cranium
Where it went: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
How much: 22,831 total

QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the

Z-2905-2018 · Class II · reported 2018-09-05 · Terminated

Why it was recalled: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Product: QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium
Where it went: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
How much: 22,831 total

QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker Q

Z-2898-2018 · Class II · reported 2018-09-05 · Terminated

Why it was recalled: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Product: QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
Where it went: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
How much: 22,831 total

QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium

Z-2909-2018 · Class II · reported 2018-09-05 · Terminated

Why it was recalled: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Product: QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium
Where it went: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
How much: 22,831 total

QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01532S, for use on the cr

Z-2906-2018 · Class II · reported 2018-09-05 · Terminated

Why it was recalled: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Product: QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01532S, for use on the cranium
Where it went: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
How much: 22,831 total

QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the

Z-2904-2018 · Class II · reported 2018-09-05 · Terminated

Why it was recalled: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Product: QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium
Where it went: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
How much: 22,831 total

QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01536S, fo

Z-2908-2018 · Class II · reported 2018-09-05 · Terminated

Why it was recalled: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Product: QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01536S, for use on the cranium
Where it went: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
How much: 22,831 total

9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile)

Z-1150-2017 · Class II · reported 2017-02-15 · Terminated

Why it was recalled: An incorrect sterility status on the label, non-sterile products labeled as sterile
Product: 9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Accessories to Medpor Implants
Where it went: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan.
How much: 619

QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (

Z-1149-2017 · Class II · reported 2017-02-15 · Terminated

Why it was recalled: An incorrect sterility status on the label, non-sterile products labeled as sterile
Product: QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to TLS Surgical Drainage System
Where it went: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan.
How much: 619

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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