OMNI LIFE SCIENCE: Medical Device Recall in 2016 - (Recall #: Z-0610-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: October 14, 2016

Date Posted: November 23, 2016

Recall Number: Z-0610-2017

Event ID: 75499

Reason for Recall:

Incorrect lot number on outer kit

Status: Terminated

Product Quantity: 15 units

Code Information:

Lot number: 19-09-021

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated