Allez Spine, LLC Allez Spine Del Mar Pedicle Screw System: IT-FN 1007, Del Mar Sterilization Tray (Part Number: 30013) Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.