Stryker Instruments

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
71
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1478-2022Class IIStryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.June 24, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPSeptember 25, 2025
K250483PhotonBlade 3; PhotonBlade 3 Smoke EvacuationSeptember 9, 2025
K250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN IntraosseousMay 15, 2025
K250327OptaBlate Radiofrequency (RF) Generator SystemApril 15, 2025
K243930Sonopet iQ Ultrasonic Aspirator System (5500-050-000)March 24, 2025
K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleMarch 21, 2025
K250374iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend March 11, 2025
K242834System 9 Sterile Battery ContainerJanuary 16, 2025
K242266PhotonBlade 3; PhotonBlade 3 Smoke EvacuationOctober 21, 2024
K241272Stryker Steri-Shield 8 Surgical Hoods and TogasOctober 16, 2024
K240526POWEReam Xia/SerratoApril 29, 2024
K232250SurgiCount+ SystemJanuary 11, 2024
K233300POWEReam 1/4 DriveDecember 26, 2023
K223294SpineJack® Expansion KitDecember 20, 2022
K222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection ManifolDecember 9, 2022
K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone CementJune 25, 2021
K172367Stryker Integrated Bipolar Cord and Tubing SetsAugust 22, 2017
K063005STRYKER T6 HOODS AND TOGASMarch 23, 2007
K062640STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000December 14, 2006
K061725STRYKER ARIA PNEUMATIC SYSTEMOctober 26, 2006