Device Recall Stryker PCD Precision System 13G Needle with Spineplex

Part Number 0505-585-000, Lot 11223012  13G Match Ground Four facet Tip Introduction Needle - PIN 0306-130-011 13G Bevel Tip Stylet - PIN 0306-131-012

Orthopedic Devices

1

No

Nationwide Distribution including FL, PA, NY, OH, IL, KY, MT, WA, CA, MO, HI, IN, SC, MS, WV, KS, TX, and WY

Stryker PCD Precision System 13G Needle with Spineplex, sterile, single use, disposable , 4 units per box. units per box. Stryker Instruments, Kalamazoo, MI || Part Number: 0505-585-000, Lot:11223012 || 13G Match Ground Four facet Tip Introduction Needle - PIN 0306-130-011 || 13G Bevel Tip Stylet - PIN 0306-131-012 || The intended use of the Stryker PCD System is for mixing bone cement and delivering it percutaneously. Bone cement is mixed in the chamber then transferred directly into an extension nozzle which has been attached to the introduction needle in the fracture site by a luer lock fitting. Cement is then dispensed directly into the fracture site under fluoroscopy