| Class 2 Device Recall Illico Ti Cannulated Polyaxial Screw | |
Date Initiated by Firm | September 25, 2012 |
Date Posted | October 29, 2012 |
Recall Status1 |
Terminated 3 on March 29, 2013 |
Recall Number | Z-0168-2013 |
Recall Event ID |
63385 |
510(K)Number | K042673 K071890 |
Product Classification |
Orthosis, spondylolisthesis spinal fixation - Product Code MNH
|
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 CA 92008-8816
|
For Additional Information Contact | 760-431-9286 |
Manufacturer 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. |
FDA Determined Cause 2 | Nonconforming Material/Component |
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. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = MNH 510(K)s with Product Code = MNH
|
|
|
|