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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm April 14, 2008
Date Posted September 02, 2008
Recall Status1 Terminated 3 on January 25, 2010
Recall Number Z-1819-2008
Recall Event ID 48116
510(K)Number K050060  
Product Classification Orthosis, Spinal Pedicle Fixation - Product Code MNI
Product Allez Spine Laguna Pedicle Screw System: IT-FN1001, Laguna Sterilization Tray # 1 (Part Number: 54003); IT-FN1002, Laguna Sterilization Tray # 2 (Part Number: 54004)
Code Information Serial /System Numbers: 002, 003, 004, 005, 006, 007, 008, 009, 010, 012, 013, 014, 015, 017, 019, 020, 021, 023, 024, 025, 029, 030, 031, 032, 034, 035, 036, 038, 039, 040, 041, 042, 043, 044, 045, 048, 049, 050, 051, 053, 054, 055, 056, 057, 059, 060, 061, 062, 063, 064, 065, 066, 067, 068, 069, 070, 071, 072, 073, 074, 076, 077, 079, 080       
Recalling Firm/
Manufacturer		 Allez Spine, LLC
2301 Dupont Dr Ste 510
Irvine CA 92612-7518
For Additional Information Contact Anil Bhalani
949-752-7885 Ext. 117
Manufacturer Reason
for Recall		 This field action was initiated because the cleaning, decontamination and sterilization procedures specified in the "Instructions for Use" for the impacted systems are incorrect. The use of these parameters in performing cleaning, decontamination and sterilization procedures may not result in clean and sterile product.
FDA Determined
Cause 2		 Error in labeling
Action Allez Spine issued a safety notice with attached fax-back attachment on April 14, 2008 via FedEx to all its hospital users, distributors and field representatives informing them of the failure of the sterilization validation and requesting them to use the new recommended sterilization parameters. The notice included copies of the updated Instructions for Use for the Allez Spine Laguna Pedicle Screw System and the Allez Spine Del Mar Pedicle Screw System. The safety notice requested that the revised recommended instructions be used for all future cleaning, decontamination and sterilization. Copies of the revised instructions were also provided with the safety notice along with links to the company website where additional copies may be downloaded. Contact Mark De Baca at 415-357-9908 if you have any questions.
Quantity in Commerce 64 systems
Distribution Nationwide to AZ, CA, CO, GA, IL, NV, TN, TX, 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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