FDA-Device2024-10-23Class II
1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures including but not limited to dental, ENT (ear, nose and throat), neuro, spine and endoscopic applications Catalog Number: 5820-066-012
Stryker Corporation
Hazard
May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is contact with cerebrospinal fluid and thus, neurosurgical/spinal procedures may be considered a population at greatest risk.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Columbia.
Affected count
307 units
Manufactured in
1941 Stryker Way, Portage, MI, United States
Products
1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures including but not limited to dental, ENT (ear, nose and throat), neuro, spine and endoscopic applications Catalog Number: 5820-066-012
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0063-2025Don't want to check this manually?
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