FDA-Device2021-02-03Class II
Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
K2M, Inc
Hazard
The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).
Sold states
Domestic: Nationwide Foreign: Australia, Canada, Netherlands, Singapore
Affected count
248 units/1 each
Manufactured in
600 Hope Pkwy SE, Leesburg, VA, United States
Products
Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0931-2021Don't want to check this manually?
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