Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

OMNIBotics iBlock Cutting Guide Recalled by OMNIlife science Inc. Due to The OMNIBotics iBlock Cutting Guide does not lock...

Date: April 12, 2019
Company: OMNIlife science Inc.
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 OMNIlife science Inc. directly.

Affected Products

OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument used during total knee arthroplasty. Specifically, the iBlock Cutting Guide is used in conjunction with the iBlock Saw Guide with the OMNIBot robotic Motor Unit, and for preparation of the bone for implant implantation. The instrument has been designed to facilitate bone preparation and implantation of the OMNI Apex Knee System.

Quantity: 9

Why Was This Recalled?

The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About OMNIlife science Inc.

OMNIlife science Inc. has 11 total recalls tracked by RecallDetector.

Related Recalls

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