Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 40mm, Winged, Catalog # LG-PW0540
FDA Recall Z-2071-2008 · Posted 2008-09-17
Recalling FirmAllez Spine, LLC
Recall StatusTerminated
Product CodeMNI
Date Initiated2007-11-07
Date Terminated2010-01-19
Product Quantity69
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.