Z-2086-2013Class II

Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to...

Name: Z-2086-2013 Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to...
Creator: Alphatec Spine, Inc.
Published: 2013-06-28
License: https://open.fda.gov/license/

Alphatec Spine, Inc. / initiated 2013-06-28 / Terminated / root cause: manufacturing process

FDA source

Alphatec Spine, Inc. began a recall of Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical... on 2013-06-28. FDA classified it as Class II and gives the reason as "The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 40mm implants, due to an off-center cannulation hole at the proximal end of the bone screw. There is a potential risk that...". 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-2086-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-28
Posted: 2013-08-27
Terminated: 2014-10-09
Recalling firm: Alphatec Spine, Inc.
Product: Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. 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.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 40mm implants, due to an off-center cannulation hole at the proximal end of the bone screw. There is a potential risk that when the screw is mated to a polyaxial screwdriver, the guide wire may not pass through the screwdriver.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: The firm, Alphatec Spine, sent an "URGENT-MEDICAL DEVICE RECALL NOTIFICATION" with response sheet dated June 28, 2013 via a combination of e-mail, Fedex, and telephone contact to its customers. The notification described the product, problem and actions to be taken. The customers were instructed to immediately return any and all affected lots of the illico Ti Cannulated Polyaxial Screw 7.5 mm x 40 mm implants that have been sent to them; if the device has previously been implanted, there is no further or additional risk post-implantation; immediately contact Alphatec Spine Customer Service Department - [email protected] on how to replace the implants; and complete and return the last page of the notification via mail to Alphatec Spine, Inc. 5818 El Camino Real, Carlsbad, CA 92008; email: sarrhenius@alphatecspine or fax to: (760) 431-0289. If you have any questions or need any additional information, please contact Director of Compliance at 760-494-9636 or email at [email protected].
Quantity in commerce: 333 screws
Distribution: Worldwide distribution: US (nationwide) including states of:US states: AZ, CA, FL, GA, IL, MD, NJ, NY, OK, PA, TN, TX,and WA ; and countries of: Spain, France, Japan. International: Spain, France, Japan.
Product codes and lots: Part Number 73875-40. Lots Affected: 647289, 648923, 649244, 649556, 649813, 650040, 650262, 650589.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2086-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2086-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27

Product code NKB

K123623Class IIIllico Mis Posterior Fixation SystemAlphatec Spine, Inc. / cleared 2013-02-14

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)