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Terminated

Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 35mm, Non-winged, Catalog # LG-PR0635

FDA Recall Z-2064-2008 · Posted 2008-09-17

Recalling FirmAllez Spine, LLC
Recall StatusTerminated
Product CodeMNI
Date Initiated2007-11-07
Date Terminated2010-01-19
Product Quantity1

Reason for Recall

This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct.

Firm Action

Allez Spine informed all parties who were in possession of the affected pedicle screws at the time of the initiation of this field action by phone on 11/08/2007 and requested the return of their inventory. All customers and consignees were contacted by the firm.

Root Cause

Device Design

Distribution Pattern

Nationwide to AZ, CA, CO & UT

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051275LAGUNA MONOAXIAL PEDICLE SCREW SYSTEMAllez Spine, LLC · 2005-12-09K050060LAGUNA PEDICLE SCREW SYSTEMAllez Spine, LLC · 2005-05-04

Official Source

View FDA Recall →

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

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