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Class 2 Device Recall Allez Spine Laguna Pedicle Screw System |
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Date Initiated by Firm |
July 30, 2007 |
Date Posted |
March 11, 2008 |
Recall Status1 |
Terminated 3 on April 09, 2012 |
Recall Number |
Z-0186-2008 |
Recall Event ID |
44911 |
510(K)Number |
K050060
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Product Classification |
Pedicle Screw System - Product Code MNI
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Product |
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 35, Catalog Number LG-PR0835, Allez Spine, LLC., Irvine, CA |
Code Information |
Lot Numbers:10294-1,10294-2,10294-3,10294-4 and 10294-5 |
Recalling Firm/ Manufacturer |
Allez Spine, LLC 2301 Dupont Drive Suite 510 Irvine CA 92612
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For Additional Information Contact |
Anil Bhalani 949-752-7885 Ext. 117
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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.
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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 |
317 |
Distribution |
Nationwide: including the states of AZ, CA, CO, GA, NV, TX and UT |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = MNI and Original Applicant = ALLEZ SPINE, LLC
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