FDAFDA · Food and drugs·Recall number Z-0168-2013
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.
Published November 7, 2012 · Recall initiated: September 25, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Alphatec Spine, Inc.
- Distributor
- Nationwide Distribution including AZ, IL, CA, SC, TN, TX, GA, CT, NY, FL, OK, LA, MO, NV,and UT.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.