OMNIlife science Inc. recalls OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel su…

Recall date

April 12, 2019

Source

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

Recall number

Z-1717-2019

FDA classification

Class II

Brand / firm

OMNIlife science Inc.

Sold / distributed

US Nationwide distribution in the states of OK, SC, and WI.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.