Allez Spine Laguna Pedicle Screw System: IT-FN1001, Laguna Sterilization Tray # 1 (Part Number: 54003); IT-FN1002, Laguna Sterilization Tray # 2 (Part Number: 54004)
FDA Recall Z-1819-2008 · Posted 2008-09-02
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Recalling FirmAllez Spine, LLC
Recall StatusTerminated
Product CodeMNI
Date Initiated2008-04-14
Date Terminated2010-01-25
Product Quantity64 systems
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.
Firm 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.
Root Cause
Error in labeling
Distribution Pattern
Nationwide to AZ, CA, CO, GA, IL, NV, TN, TX, UT
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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