Recall Z-1421-2013— Alphatec Spine, Inc.
Class II · Terminated
Class II FDA medical device recall by Alphatec Spine, Inc., initiated 2013-05-06, terminated 2014-09-25. It names one FDA 510(k) clearance: K113366. Product: Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.. Reason: 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.
- Recalling firm
- Alphatec Spine, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-06
- Terminated
- 2014-09-25
- Firm location
- Carlsbad, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.