FDA-Device2013-06-05Class II
Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.
Alphatec Spine, Inc.
Hazard
Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia" Autolok set screw may interfere with the top of the screw head prior to fully locking the rod. If this condition occurs, the polyaxial screw head and rod may fail to provide a rigid construct under loading. To date there have been no reports of patient injury, adve
Sold states
Nationwide Distribution.
Affected count
1,814
Manufactured in
5818 El Camino Real, N/A, Carlsbad, CA, United States
Products
Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1421-2013Don't want to check this manually?
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