Stryker Instruments

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
74
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
K261544Hydro Irrigation SystemJune 17, 2026
K253679Hydro Irrigation SystemMay 8, 2026
K252282SurgiCount+ SystemMarch 16, 2026
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