Date Initiated by Firm | April 14, 2008 |
Date Posted | September 02, 2008 |
Recall Status1 |
Terminated 3 on January 25, 2010 |
Recall Number | Z-1820-2008 |
Recall Event ID |
48116 |
510(K)Number | K051275 |
Product Classification |
Thoracolumbosacral Pedicle Screw System - Product Code NKB
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Product | Allez Spine Del Mar Pedicle Screw System: IT-FN 1007, Del Mar Sterilization Tray (Part Number: 30013) |
Code Information |
Serial /System Numbers: DM0001, DM0002 |
Recalling Firm/ Manufacturer |
Allez Spine, LLC 2301 Dupont Dr Ste 510 Irvine CA 92612-7518
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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 | 2 systems |
Distribution | Nationwide to AZ, CA, CO, GA, IL, NV, TN, TX, 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 = NKB
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