Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation Recalled by OMNI LIFE SCIENCE Due to Incorrect lot number on outer kit

Date: October 14, 2016
Company: OMNI LIFE SCIENCE
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact OMNI LIFE SCIENCE directly.

Affected Products

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

Quantity: 15 units

Why Was This Recalled?

Incorrect lot number on outer kit

Where Was This Sold?

This product was distributed to 3 states: MD, OK, TX

Affected (3 states)Not affected

About OMNI LIFE SCIENCE

OMNI LIFE SCIENCE has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report