OMNI LIFE SCIENCE recalls OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is inte…

Recall date

October 14, 2016

Source

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

Recall number

Z-0610-2017

FDA classification

Class III

Brand / firm

OMNI LIFE SCIENCE

Sold / distributed

Worldwide Distribution: US distribution to OK, MD, TX and country of: Australia.

Why it was recalled

Incorrect lot number on outer kit

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: Total Knee Arthroplasty