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Alphatec Spine, Inc. recalls Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilizati
Recalled June 5, 2013 · FDA recall Z-1421-2013 · Alphatec Spine
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 · FDA Class II
Units
1,814
Sold at
Nationwide Distribution.
Description
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
Product
Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.
Manufacturer(s)
Alphatec Spine, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →