Integra External Fixation System Rocker Bottom # recalled over mold contamination

Recall date

July 1, 2016

Source

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

Official notice title

Integra LifeSciences Corp. recalls Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable t…

Recall number

Z-2296-2016

FDA classification

Class II

Brand / firm

Integra LifeSciences Corp.

Sold / distributed

Distributed in the US to the states of FL, VA, OK, CO, DC, and IN.

Why it was recalled

The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.

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

What was recalled

Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of external fixation.