Z-0491-2010

Zodiac Polyaxial Spinal Fixation System. A spinal interlaminal fixation orthosis is a device intended to be...

Name: Z-0491-2010 Zodiac Polyaxial Spinal Fixation System. A spinal interlaminal fixation orthosis is a device intended to be...
Creator: Alphatec Spine, Inc.
Published: 2008-11-03
License: https://open.fda.gov/license/

Alphatec Spine, Inc. / initiated 2008-11-03 / Terminated / root cause: labeling and UDI

FDA source

Alphatec Spine, Inc. began a recall of Zodiac Polyaxial Spinal Fixation System. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless... on 2008-11-03. The reason FDA records is "Alphatec Spine recently discovered that this lot of screws has the incorrect length laser etched on one side of the screw body. As a result, they are conducting a voluntary recall of the Zodiac Titanium cannulated...". 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-0491-2010
Status: Terminated
Initiated: 2008-11-03
Posted: 2009-12-07
Terminated: 2009-12-08
Recalling firm: Alphatec Spine, Inc.
Product: Zodiac Polyaxial Spinal Fixation System. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.
Product code: KWP Appliance, Fixation, Spinal Interlaminal
Reason for recall: Alphatec Spine recently discovered that this lot of screws has the incorrect length laser etched on one side of the screw body. As a result, they are conducting a voluntary recall of the Zodiac Titanium cannulated polyaxial screw 6.5 mm x 50 mm L.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Alphatec Spine contacted consignees via phone on October 16, 2008 and requested that consignees immediately remove the Zodiac Titanium cannulated polyaxial screws (6.5 mm x 50 mm L) from the surgical set to help ensure that they will not be used in surgery. There is a script the company developed to assure consistent responses to customers, and a phone number for more information. The strategy calls for products to be returned to Alphatec Spine. The company will arrange to have Federal Express contact the consignees for pick-up of the screws. Follow up questions are directed to the company at 1-800-922-1356.
Quantity in commerce: 56
Distribution: AZ, CA, FL, TX
Product codes and lots: Part Number: 62665-50 Lot Number: 617945

Product code KWP

K042673Class IIZodiac Polyaxial Spinal Fixation SystemAlphatec/Nexmed / cleared 2004-10-27

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)