| ||Class 2 Recall|
Illico Ti Cannulated Polyaxial Screw
||October 29, 2012
||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 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
|Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad, California 92008-8816
|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.
||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@example.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
||Nationwide Distribution including AZ, IL, CA, SC, TN, TX, GA, CT, NY, FL, OK, LA, MO, NV,and UT.