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 Class 2 Recall
Illico Ti Cannulated Polyaxial Screw		see related information
Date Posted October 29, 2012
Recall Number Z-0168-2013
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.
Code Information 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
Recalling Firm/
Manufacturer		 Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad, California 92008-8816
Consumer Instructions Contact the recalling firm for information
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 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.
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.
 
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