Product Wiki · Recalls · U.S. FDA — Device Enforcement

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. — recall Z-2086-2013

U.S. FDA — Device Enforcement · United States · 2013-06-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2086-2013
Date of alert
2013-06-28
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Alphatec Spine, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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