Innovasis, Inc recalls Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Pac…

Recall date

December 7, 2015

Source

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

Recall number

Z-0662-2016

FDA classification

Class II

Brand / firm

Innovasis, Inc

Sold / distributed

Distributed in US -- CA; KS; OH; & TX.

Why it was recalled

Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.

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

What was recalled

Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. Intended for use in the non-cervical area of the spine.