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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 System see related information
Date Initiated by Firm July 30, 2007
Date Posted March 11, 2008
Recall Status1 Terminated 3 on April 09, 2012
Recall Number Z-0188-2008
Recall Event ID 44911
510(K)Number K050060  
Product Classification Pedicle Screw System - Product Code MNI
Product Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 45, Catalog Number LG-PR0845, Allez Spine, LLC., Irvine, CA
Code Information Lot Numbers: 10296-1,10296-2,10296-3,10296-4, and 10296-5 
Recalling Firm/
Manufacturer		 Allez Spine, LLC
2301 Dupont Drive
Suite 510
Irvine CA 92612
For Additional Information Contact Anil Bhalani
949-752-7885 Ext. 117
Manufacturer Reason
for Recall		 Screw Shank Failure; separation of the screw shank portion from the pedicle head portion of the Size 8 Pedicle Screw, when torquing down the single piece locking nut during implantation.
FDA Determined
Cause 2		 Device Design
Action On July 30, 2007 Allez Spine notified all its field representatives and distributors via email of a potential for failure of the Size 8 Pedicle Screws when used in combination with the single piece locking nuts and instructed them to return all unused inventory of Size 8 Screws and the two piece Locking Nuts with saddle. This action was to be carried out to the retail level-hospital, clinic, lab, and physicians sold the product. The email also had an attachment of a list of expected frequently asked questions (FAQ) from surgeons and answers to help them respond. A second Notice to all users was sent by the recalling firm on Feb 29, 2008, to request follow-up of implanted units.
Quantity in Commerce 325
Distribution Nationwide: including the states of AZ, CA, CO, GA, NV, TX and UT
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MNI and Original Applicant = ALLEZ SPINE, LLC
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