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OMNIlife science Inc. recalls OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel sur
Recalled June 12, 2019 · FDA recall Z-1717-2019 · OMNIlife science
Hazard
The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use. · FDA Class II
Units
9
Sold at
US Nationwide distribution in the states of OK, SC, and WI.
Description
The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use.
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.
Manufacturer(s)
OMNIlife science Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →