Z-1820-2008

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

Name: Z-1820-2008 Allez Spine Del Mar Pedicle Screw System: IT-FN 1007, Del Mar Sterilization Tray (Part Number: 30013)
Creator: Allez Spine, LLC
Published: 2008-04-14
License: https://open.fda.gov/license/

Allez Spine, LLC / initiated 2008-04-14 / Terminated / root cause: labeling and UDI

FDA source

Allez Spine, LLC began a recall of Allez Spine Del Mar Pedicle Screw System: IT-FN 1007, Del Mar Sterilization Tray (Part Number: 30013) on 2008-04-14. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1820-2008
Status: Terminated
Initiated: 2008-04-14
Posted: 2008-09-02
Terminated: 2010-01-25
Recalling firm: Allez Spine, LLC
Product: Allez Spine Del Mar Pedicle Screw System: IT-FN 1007, Del Mar Sterilization Tray (Part Number: 30013)
Product code: NKB Thoracolumbosacral Pedicle Screw System
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.
Root cause tag: labeling and UDI
FDA root cause: 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
Product codes and lots: Serial /System Numbers: DM0001, DM0002

Product code NKB

K051275Class IILaguna Monoaxial Pedicle Screw SystemAllez Spine, LLC / cleared 2005-12-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)