Zodiac Polyaxial Spinal Fixation System

• • Terminated Z-0168-2013 FDA Class II ·initiated 25 Sep 2012 ·on shared 510(k) K042673

  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.

• • Terminated Z-0967-2013 FDA Class II ·initiated 6 Jul 2011

  The rods were incorrectly laser etched as ILLICO Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length.

• • Terminated Z-0491-2010 FDA Unclassified (pre-2012) ·initiated 3 Nov 2008

  Alphatec Spine recently discovered that this lot of screws has the incorrect length laser etched on one side of the screw body. As a result, they are conducting a voluntary recall of the Zodiac Titanium cannulated polyaxial screw 6.5 mm x 50 mm L.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K042673 ↗

FDA Product Code

KWP

Device Class

Class II

Regulation

21 CFR Part 888.3050

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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