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

Recalled November 23, 2016 · FDA recall Z-0610-2017 · OMNI LIFE SCIENCE

Hazard

Incorrect lot number on outer kit · FDA Class III

Units

15 units

Sold at

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

Description

Incorrect lot number on outer kit

Product

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

Manufacturer(s)

OMNI LIFE SCIENCE

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →