Z-0168-2013Class II

ILLlCO MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orthosis, Spinal Pedical...

Name: Z-0168-2013 ILLlCO MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orthosis, Spinal Pedical...
Creator: Alphatec Spine, Inc.
Published: 2012-09-25
License: https://open.fda.gov/license/

Alphatec Spine, Inc. / initiated 2012-09-25 / Terminated / root cause: manufacturing process

FDA source

Alphatec Spine, Inc. began a recall of ILLlCO MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orthosis, Spinal Pedical Fixation Orthosis, Spondylolisthesis Spinal Fixation... on 2012-09-25. FDA classified it as Class II and gives the reason as "The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did not completely fit/pass through the tip of certain Illico Ti Cannulated Polyaxial Screws, therefore rendering...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0168-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-25
Posted: 2012-10-29
Terminated: 2013-03-29
Recalling firm: Alphatec Spine, Inc.
Product: ILLlCO MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orthosis, Spinal Pedical Fixation Orthosis, Spondylolisthesis Spinal Fixation The ILLICO MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. When used for a minimally invasive posterior approach ILLlCO MIS Instrumentation is used in conjunction with polyaxial screw components. The ILLICO MIS Posterior Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the ILLICO MIS Posterior Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
Product code: MNH Orthosis, Spondylolisthesis Spinal Fixation
Reason for recall: The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did not completely fit/pass through the tip of certain Illico Ti Cannulated Polyaxial Screws, therefore rendering such screws nonfunctional.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Alphatec Spine sent an Urgent Medical Device Recall Notification letter dated September 25, 2012, to all affected customers. The letter identifed the product, the problem, and the action to be taken by the customer. Customers were instructed to contact Alphatec Spine's Customers Service Department ([email protected]) immediately for instructions on how to return the affected product. Customers were asked to fill out the lower portion of the letter and fax to (760) 431-0289 to confirm that they have read the notification and will take all necessary removal actions. For questions customers were instructed to call 1-800-922-1356. For questions regarding this recall call 760-431-9286.
Quantity in commerce: 209 screws
Distribution: Nationwide Distribution including AZ, IL, CA, SC, TN, TX, GA, CT, NY, FL, OK, LA, MO, NV,and UT.
Product codes and lots: Product Codes: KW, MNI, MNH. Part NumberlLot Number: ¿PART DESCRIPTION LOT 7384S-30 Ti CANNULATED POLYAXIAL SCREW 4.5mm X 30mm 646501 73845-35 Ti CANNULATED POLYAXIAL SCREW 4.5mm X 35mm 646502 73845-40 Ti CANNULATED POLYAXIAL SCREW 4.5mm X 40mm 646503 73845-45 Ti CANNULATED POLYAXIAL SCREW 4.5mm X 45mm 646504 73855-35 Ti CANNULATED POLYAXIAL SCREW 5.5mm X 35mm 646510 73865-30 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 30mm 646515 73865-35 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 35mm 646516 73865-40 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 40mm 646517 73865-45 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 45mm 646542 73865-50 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 50mm 646543 73875-35 Ti CANNULATED POLYAXIAL SCREW 7.5mm X 35mm 646546 73875-45 Ti CANNULATED POLYAXIAL SCREW 7.5mm X 45mm 646548 73875-50 Ti CANNULATED POLYAXIAL SCREW 7.5mm X 50mm 646549

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0168-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0168-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-07	2012-10-29

Product code MNH

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)