OMNIlife science Inc.: Medical Device Recall in 2019 - (Recall #: Z-1717-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 12, 2019

Date Posted: June 12, 2019

Recall Number: Z-1717-2019

Event ID: 82797

Reason for Recall:

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

Status: Terminated

Product Quantity: 9

Code Information:

MI1218

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated