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

FDA device recall Z-0168-2013 · posted 2012-10-29 · Terminated

Recall details

Recalling firm

Alphatec Spine, Inc.

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.

Action taken

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 (customerservice@alphatecspine.com) 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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MNH

Quantity affected

209 screws

Distribution

Nationwide Distribution including AZ, IL, CA, SC, TN, TX, GA, CT, NY, FL, OK, LA, MO, NV,and UT.

Date initiated

2012-09-25

Date posted

2012-10-29

Date terminated

2013-03-29

Location

Carlsbad, CA

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