FDA recall Z-1717-2019

OMNIlife science Inc. · Class II · device

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.

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2019-04-12
Report date
2019-06-12
Termination date
2020-05-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Raynham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1717-2019