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.
FDA Recall Z-1717-2019 · Posted None
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Recalling FirmOMNIlife science Inc.
Recall StatusTerminated
Product CodeOLO
Date Initiated2019-04-12
Date Terminated2020-05-14
Product Quantity9
Reason for Recall
The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as
intended and may loosen during use.
Firm Action
On April 12, 2019, the firm notified customers of the recall through phone, email, and federal mailing titled URGENT MEDICAL DEVICE ADVISORY NOTICE. Customers were informed that the locking mechanism on the iBlock Cutting Guide may loosen during use.
Customers were asked to:
-Immediately quarantine lot MI1218
-Return product to the firm
-Acknowledge receipt of the notice be completing and returning the Receipt form by fax or email.
The firm's investigation is ongoing.
For further information contact Christina Rovaldi, Sr. Regulatory Affairs Specialist at 774-
226-1847 or 800-448-6664.
Company contact hours are Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of OK, SC, and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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