Leucadia Autolok" Polyaxial Pedicle Screw System — Class II medical device recall Z-1421-2013
Terminated recall by Alphatec Spine, Inc., reported 2013-06-05, distributed nationwide. Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange o
| Recall number | Z-1421-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alphatec Spine, Inc., Carlsbad, CA, United States |
| Recall initiated | 2013-05-06 |
| Classified | 2013-05-28 |
| Reported by FDA | 2013-06-05 |
| Terminated | 2014-09-25 |
| Distributed | Nationwide (US) |
| Quantity | 1,814 |
| Reason classes | device malfunction |
| Model numbers | LA-CTOO02, LA-HDOO01, LA-HSS0010, LA-PS0530, LA-PS0535, LA-PS0540, LA-PS0545, LA-PS0550, LA-PS0630, LA-PS0635, LA-PS0640, LA-PS0645, LA-PS0650, LA-PS0655, LA-PS0660, LA-PS0730, LA-PS0735, LA-PS0740, LA-PS0745, LA-PS0750, LA-PS0755, LA-PS0830, LA-PS0835, LA-PS0840, LA-PS0845 and 4 more |
Product
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.