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U.S. Department of Health and Human Services

Class 2 Device Recall Allez Spine Laguna Pedicle Screw System

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 Class 2 Device Recall Allez Spine Laguna Pedicle Screw Systemsee related information
Date Initiated by FirmNovember 07, 2007
Date PostedSeptember 17, 2008
Recall Status1 Terminated 3 on January 19, 2010
Recall NumberZ-2061-2008
Recall Event ID 48185
510(K)NumberK050060 K051275 
Product Classification Orthosis, spinal pedicle fixation - Product Code MNI
ProductAllez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 35mm, Non-winged, Catalog # LG-PR0535
Code Information Catalog # LG-PR0535
Recalling Firm/
Manufacturer		 Allez Spine, LLC
2301 Dupont Dr Ste 510
Irvine CA 92612-7518
For Additional Information ContactAnil Bhalani
949-752-7885 Ext. 117
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionAllez 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.
Quantity in Commerce3
DistributionNationwide to AZ, CA, CO & UT
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MNI
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