Z-0191-2008

Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 80...

Name: Z-0191-2008 Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 80...
Creator: Allez Spine, LLC
Published: 2007-07-30
License: https://open.fda.gov/license/

Allez Spine, LLC / initiated 2007-07-30 / Terminated / root cause: design

FDA source

Allez Spine, LLC began a recall of Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 80, Catalog Number LG-PR0880, Allez Spine, LLC... on 2007-07-30. The reason FDA records is "Screw Shank Failure; separation of the screw shank portion from the pedicle head portion of the Size 8 Pedicle Screw, when torquing down the single piece locking nut during implantation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0191-2008
Status: Terminated
Initiated: 2007-07-30
Posted: 2008-03-11
Terminated: 2012-04-09
Recalling firm: Allez Spine, LLC
Product: Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 80, Catalog Number LG-PR0880, Allez Spine, LLC., Irvine, CA
Product code: MNI Orthosis, Spinal Pedicle Fixation
Reason for recall: Screw Shank Failure; separation of the screw shank portion from the pedicle head portion of the Size 8 Pedicle Screw, when torquing down the single piece locking nut during implantation.
Root cause tag: design
FDA root cause: Device Design
Action: On July 30, 2007 Allez Spine notified all its field representatives and distributors via email of a potential for failure of the Size 8 Pedicle Screws when used in combination with the single piece locking nuts and instructed them to return all unused inventory of Size 8 Screws and the two piece Locking Nuts with saddle. This action was to be carried out to the retail level-hospital, clinic, lab, and physicians sold the product. The email also had an attachment of a list of expected frequently asked questions (FAQ) from surgeons and answers to help them respond. A second Notice to all users was sent by the recalling firm on Feb 29, 2008, to request follow-up of implanted units.
Quantity in commerce: 14
Distribution: Nationwide: including the states of AZ, CA, CO, GA, NV, TX and UT
Product codes and lots: Lot Number: 10528

Product code MNI

K050060Class IILaguna Pedicle Screw SystemAllez Spine, LLC / cleared 2005-05-04

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)