Medicrea International recalls Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590 B36027500 B36027570 B36027580 B36027…

Recall date

January 28, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1473-2020

FDA classification

Class II

Brand / firm

Medicrea International

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of CO, FL, GA, LA, OH, and RI. International distribution to Greece and Portugal.

Why it was recalled

An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction step.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590 B36027500 B36027570 B36027580 B36027590 B36028500 B36028570 B36028580 B36028590 B36029500 B36029570 B36029580 B36029590 Screws manufactured in titanium alloy Ti-6Al-4V LI conforming to ISO5832-3 and ASTM. F136 specifications. These screws are part of an internal fixation system composed of hooks, rods, plates, cross links, connection and locking devices.