Stryker Instruments
FDA Regulatory Profile
Stryker Instruments appears in FDA public data with 1 recall, 74 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1478-2022, Class II) was initiated on June 24, 2022. Its most recent 510(k) clearance was granted on June 17, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 74
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1478-2022 | Class II | Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures. | June 24, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K261544 | Hydro Irrigation System | June 17, 2026 |
| K253679 | Hydro Irrigation System | May 8, 2026 |
| K252282 | SurgiCount+ System | March 16, 2026 |
| K251971 | RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RP | September 25, 2025 |
| K250483 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | September 9, 2025 |
| K250213 | OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous | May 15, 2025 |
| K250327 | OptaBlate Radiofrequency (RF) Generator System | April 15, 2025 |
| K243930 | Sonopet iQ Ultrasonic Aspirator System (5500-050-000) | March 24, 2025 |
| K243958 | Consolidated Operating Room Equipment (CORE) 2 Console | March 21, 2025 |
| K250374 | iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend | March 11, 2025 |
| K242834 | System 9 Sterile Battery Container | January 16, 2025 |
| K242266 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | October 21, 2024 |
| K241272 | Stryker Steri-Shield 8 Surgical Hoods and Togas | October 16, 2024 |
| K240526 | POWEReam Xia/Serrato | April 29, 2024 |
| K232250 | SurgiCount+ System | January 11, 2024 |
| K233300 | POWEReam 1/4 Drive | December 26, 2023 |
| K223294 | SpineJack® Expansion Kit | December 20, 2022 |
| K222552 | 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifol | December 9, 2022 |
| K211238 | SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement | June 25, 2021 |
| K172367 | Stryker Integrated Bipolar Cord and Tubing Sets | August 22, 2017 |