Stryker GmbH

FDA Regulatory Profile

Summary

Total Recalls
70
510(k) Clearances
270
Inspections
6
Compliance Actions
0

Known Names

physio control international, stryker-corporation, k2m group holdings, physio control, stryker medical, stryker leibinger gmbh co kg, stryker craniomaxillofacial, mako surgical, wright medical group, stryker-instruments

Recent Recalls

NumberClassProductDate
Z-1914-2025Class IILong Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.May 28, 2025
Z-1939-2025Class IIFemoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.May 22, 2025
Z-1940-2025Class IIFemoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.May 22, 2025
Z-1621-2025Class IIGuide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;March 28, 2025
Z-1620-2025Class IIGuide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;March 28, 2025
Z-2219-2024Class IIStryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.May 9, 2024
Z-1085-2024Class IIStryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cmDecember 6, 2023
Z-1084-2024Class IIStryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cmDecember 6, 2023
Z-1191-2023Class IIstryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device February 7, 2023
Z-1011-2022Class IISmart Toe II Intramedullary Arthrodesis ImplantMarch 28, 2022
Z-2170-2021Class IINail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407SMay 27, 2021
Z-2171-2021Class IINail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406SMay 27, 2021
Z-0457-2021Class IIOsteosynthesis Compression Staple EasyClipSeptember 25, 2020
Z-2384-2020Class IIStryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: May 7, 2020
Z-2386-2020Class IIStryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Catalog Number: 18965050S - Product Usage: May 7, 2020
Z-2381-2020Class IIStryker Locking Screw, Fully Threaded T2 Tibia ¿5x30 mm Catalog Number: 18965030S - Product UsageMay 7, 2020
Z-2378-2020Class IIStryker End Cap T2 Humerus ¿6mm, 15mm height Catalog Number: 18300015S - Product Usage: Stryker iMay 7, 2020
Z-2374-2020Class IIStryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker imMay 7, 2020
Z-2375-2020Class IIStryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are sMay 7, 2020
Z-2376-2020Class IIStryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker impMay 7, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemFebruary 3, 2026
K253202Hoffmann LRF SystemDecember 19, 2025
K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemAugust 20, 2025
K250163T2 Alpha Femur Retrograde Nailing SystemAugust 13, 2025
K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating SyOctober 6, 2024
K233919VariAx 2 Distal Radius SystemMarch 25, 2024
K233741Hoffmann LRF SystemDecember 21, 2023
K230045HipCheckSeptember 29, 2023
K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMSeptember 20, 2023
K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea HumerAugust 18, 2023
K231257Pangea Utility Plating System, Pangea PlatformAugust 18, 2023
K230512Gamma4 SystemJune 9, 2023
K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®May 19, 2023
K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemApril 27, 2023
K230754L12 LED Light Source with AIMApril 11, 2023
K223772PRO Plating System, Stryker Trauma Pelvic Set (Matta)April 7, 2023
K2306051788 4K Camera System with Advanced Imaging ModalityMarch 31, 2023
K2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)February 23, 2023
K222309Gamma4 SystemNovember 15, 2022
K2221301688 4K Camera System with Advanced Imaging ModalityAugust 19, 2022