Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm…

Date

Sept. 4, 2013

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

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.

Reason

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.

Distribution pattern

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.

Quantity

333 screws

Codes and lots

Part Number 73875-40. Lots Affected: 647289, 648923, 649244, 649556, 649813, 650040, 650262, 650589.

Recall started

June 28, 2013

Device type

Thoracolumbosacral Pedicle Screw System

Root cause (FDA)

Equipment maintenance

What the company told customers

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 - customerservice@alphatecspine.com 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 dmcgrath@alphatecspine.com.

Recall number

Z-2086-2013

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2086-2013. The agency record governs; check it and the company before acting.