medical Class II Updated 2019-06-12

OMNIlife science Inc. recalls OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage:

Recalled Product

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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: MI1218
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →