Stryker Leibinger GmbH & Co. KG

FDA Regulatory Profile

Summary

Total Recalls
25
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1885-2024Class II8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a nextApril 4, 2024
Z-1785-2024Class IIStryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid March 29, 2024
Z-1234-2023Class IIPatient-Fitted Temporomandibular (TMJ) Reconstruction ProsthesisDecember 6, 2022
Z-0715-2022Class IIMEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032December 29, 2021
Z-1436-2021Class IIDirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injectioApril 1, 2021
Z-2901-2018Class IIQUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-0June 22, 2018
Z-2912-2018Class IIAXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use onJune 22, 2018
Z-2905-2018Class IIQUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for uJune 22, 2018
Z-2910-2018Class IIAXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for uJune 22, 2018
Z-2906-2018Class IIQUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01532S, for useJune 22, 2018
Z-2903-2018Class IIQUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on June 22, 2018
Z-2913-2018Class IIAXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-0154June 22, 2018
Z-2898-2018Class IIQUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S TheJune 22, 2018
Z-2909-2018Class IIQUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on tJune 22, 2018
Z-2915-2018Class IIAXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on thJune 22, 2018
Z-2907-2018Class IIQUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-0June 22, 2018
Z-2904-2018Class IIQUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for June 22, 2018
Z-2914-2018Class IIAXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-0154June 22, 2018
Z-2908-2018Class IIQUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-0June 22, 2018
Z-2911-2018Class IIAXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for useJune 22, 2018