Manufacturer

Stryker Leibinger GmbH & Co. KG

25 recalls in our database name Stryker Leibinger GmbH & Co. KG as the manufacturing or recalling firm.

What the numbers show

Total: 25
Critical: 0
Severe: 0
Most recent: 2024-05-29

Of the 25 recalls from Stryker Leibinger GmbH & Co. KG we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 25

HighFDA (Devices)·Z-1885-2024·2024-05-29
Scopis ENT Navigation Software Contains Visual Guidance Alignment Error
Unreleased software in Scopis ENT surgical navigation systems causes visual guidance to display inaccurately relative to physical reference points, affecting surgical precision. Affects 705 units nationwide.
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. T
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1785-2024·2024-05-15
Stryker Dynamic Mesh Mislabeled with Incorrect Catalog Number
Stryker shipped 63 units of cranial mesh labeled as catalog 56-90614 (Gold) but actually containing 56-90314 (Blue) mesh. The mislabeling may cause procedural delays.
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1234-2023·2023-03-15
TMJ Reconstruction Prosthesis Recalled for Lacking FDA Regulatory Approval
A patient-fitted temporomandibular (TMJ) reconstruction prosthesis from Stryker Leibinger was recalled after being shipped without FDA regulatory approval. The single device distributed to a customer in Massachusetts has not been evaluated for safety and effectiveness.
Product
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0715-2022·2022-03-09
Stryker medical implant recalled for manufacturing defect in barrier layer
Stryker is recalling MEDPOR Titan OFW implants after one unit was found with an incorrectly placed barrier layer. The defect resulted from manufacturing error rather than design.
Product
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1436-2021·2021-04-28
Stryker DirectInject Bone Cement Recalled Due to Injection Failure
Stryker is recalling 321 units of DirectInject bone cement because the paste cannot be injected 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2911-2018·2018-09-05
Stryker AXS PP Cranium Plates Recalled for Packaging Compromise
Stryker is recalling 22,831 AXS PP cranium plates because the sterile packaging may become compromised after three years.
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
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2907-2018·2018-09-05
Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise
Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.
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
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2910-2018·2018-09-05
Stryker AXS PP Cranium Plates Recalled for Packaging Compromise
Stryker is recalling 22,831 AXS PP cranium plates because the sterile packaging may become compromised after three years.
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
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2902-2018·2018-09-05
Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise
Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years, potentially affecting sterility.
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
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2899-2018·2018-09-05
Stryker QuickFlap Sterile Procedure Packs Recalled for Packaging Compromise
Stryker is recalling QuickFlap Sterile Procedure Packs because the sterile barrier may become compromised after three years.
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 an
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2914-2018·2018-09-05
Stryker AXS PP Burr Hole Cover Recall Due to Packaging Compromise
Stryker is recalling AXS PP burr hole covers because the sterile packaging may become compromised after three years, potentially affecting sterility.
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
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2908-2018·2018-09-05
Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise
Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.
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
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2915-2018·2018-09-05
Stryker AXS PP Burr Hole Cover Recall Due to Packaging Compromise
Stryker is recalling AXS PP Burr Hole Covers because the sterile packaging may become compromised after three years, potentially affecting sterility.
Product
AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2900-2018·2018-09-05
Stryker QUIKFLAP Cranium Plates Recalled for Packaging Compromise
Stryker is recalling QUIKFLAP cranium plates because the sterile packaging may become compromised after three years.
Product
QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium.
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2913-2018·2018-09-05
Stryker AXS PP Burr Hole Cover Recall for Packaging Compromise
Stryker is recalling AXS PP burr hole covers because the sterile packaging may become compromised after three years.
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
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2905-2018·2018-09-05
Stryker QUIKFLAP Cranium Plates Recalled for Sterile Barrier Compromise
Stryker Leibinger is recalling QUIKFLAP cranium plates because the sterile packaging may become compromised after three years, potentially affecting sterility.
Product
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2909-2018·2018-09-05
Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise
Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.
Product
QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2904-2018·2018-09-05
Stryker QUIKFLAP Cranium Plates Recalled for Sterile Barrier Compromise
Stryker is recalling QUIKFLAP cranium plates because the sterile packaging may become compromised after three years, potentially affecting sterility.
Product
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2903-2018·2018-09-05
Stryker Quikflap Burr Hole Cover Recall Due to Packaging Compromise
Stryker is recalling Quikflap burr hole covers because the sterile packaging may become compromised after three years.
Product
QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on the cranium
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2912-2018·2018-09-05
Stryker AXS PP Cranium Plates Recalled for Packaging Compromise
Stryker is recalling 22,831 AXS PP cranium plates because the sterile packaging may become compromised after three years.
Product
AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2901-2018·2018-09-05
Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise
Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.
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
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2906-2018·2018-09-05
Stryker QUIKFLAP Cranial Plates Recalled for Sterile Barrier Compromise
Stryker is recalling QUIKFLAP cranial plates because the sterile packaging may become compromised after three years, potentially affecting sterility.
Product
QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01532S, for use on the cranium
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2898-2018·2018-09-05
Stryker QuickFlap Sterile Procedure Pack Recalled for Packaging Compromise
Stryker is recalling QuickFlap Sterile Procedure Packs because the sterile barrier may become compromised after three years.
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 a
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1149-2017·2017-02-15
Stryker Leibinger Recalls Surgical Drainage Accessories Due to Sterility Labeling Error
Stryker Leibinger is recalling QUINTUBE Monitor Packs and SPG Bulb Drain Systems because non-sterile products were incorrectly 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
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1150-2017·2017-02-15
Stryker Leibinger Recalls Non-Sterile Medpor Implant Sizer Sets Due to Labeling Error
Stryker Leibinger is recalling specific non-sterile Medpor implant sizer sets because they were incorrectly labeled as sterile. The recall covers 619 units distributed in the US and several international countries.
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
Category
Medical Device
Distribution
Distributed nationwide