Recall Z-2086-2013 ยท NKB Thoracolumbosacral Pedicle Screw System
Alphatec Spine, Inc.
Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. 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.
| Date | Aug 27, 2013 (initiated Jun 28, 2013) |
| Status | Terminated |
| Reason | The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 40mm implants, due to an off-center cannulation hole at the proximal end of the bone screw. There is a potential risk that when the screw is mated to a polyaxial screwdriver, the guide wire may not pass through the screwdriver. |
| Root cause | Equipment maintenance |
| Action | The firm, Alphatec Spine, sent an "URGENT-MEDICAL DEVICE RECALL NOTIFICATION" with response sheet dated June 28, 2013 via a combination of e-mail, Fedex, and telephone contact to its customers. The notification described the product, problem and actions to be taken. The customers were instructed to immediately return any and all affected lots of the illico Ti Cannulated Polyaxial Screw 7.5 mm x 40 mm implants that have been sent to them; if the device has previously been implanted, there is no further or additional risk post-implantation; immediately contact Alphatec Spine Customer Service Dep |
| Quantity | 333 screws |
| Distribution | Worldwide distribution: US (nationwide) including states of:US states: AZ, CA, FL, GA, IL, MD, NJ, NY, OK, PA, TN, TX,and WA ; and countries of: Spain, France, Japan. International: Spain, France, Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123623 | ILLICO MIS POSTERIOR FIXATION SYSTEM Alphatec Spine, Inc., Feb 14, 2013 |