Reported Sep 4, 2013 · Terminated

Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate…

Alphatec Spine, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Alphatec Spine, Inc. · 5818 El Camino Real · Carlsbad, CA · 92008-8816

Is this the product you have?

  • 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.
Lot codes and dates
  • Part Number 73875-40
  • Lots Affected
    • 647289
    • 648923
    • 649244
    • 649556
    • 649813
    • 650040
    • 650262
    • 650589
Amount recalled
333 screws

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 9, 2014 · Data as of Sep 19, 5:29 PM UTC

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