Recall Z-0168-2013 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
Alphatec Spine, Inc.
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 developm
| Date | Oct 29, 2012 (initiated Sep 25, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 quest |
| Quantity | 209 screws |
| Distribution | Nationwide Distribution including AZ, IL, CA, SC, TN, TX, GA, CT, NY, FL, OK, LA, MO, NV,and UT. |
| FDA record | Open on fda.gov |