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Terminated

Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.

FDA Recall Z-1421-2013 · Posted 2013-05-28

Recalling FirmAlphatec Spine, Inc.
Recall StatusTerminated
Product CodeNKB
Date Initiated2013-05-06
Date Terminated2014-09-25
Product Quantity1,814

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

Firm Action

Alphatec Spine initiated recall by contacting customers via telephone and/or email on 05/06/2013. An Urgent Medical Device Recall Notification letter along with a response form were sent via FedEx to all affected accounts. The letter identified the product, problem, and actions to be taken by the customers.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113366LEUCADIA AUTOLOK PEDICLE SCREW SYSTEMPhygen, LLC · 2012-01-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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