Z-1717-2019Class II

OMNIBotics iBlock Cutting Guide, 4146-1000 -

Name: Z-1717-2019 OMNIBotics iBlock Cutting Guide, 4146-1000 -
Creator: OMNIlife science Inc.
Published: 2019-04-12
License: https://open.fda.gov/license/

Omni Life Science, Inc. / initiated 2019-04-12 / Terminated

FDA source

OMNIlife science Inc. began a recall of OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument used during total knee... on 2019-04-12. FDA classified it as Class II and gives the reason as "The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1717-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-12
Posted: 2019-06-04
Terminated: 2020-05-14
Recalling firm: Omni Life Science, Inc.
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.
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use.
FDA root cause: Under Investigation by 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.
Quantity in commerce: 9
Distribution: US Nationwide distribution in the states of OK, SC, and WI.
Product codes and lots: MI1218

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1717-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1717-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-04

Product code OLO

K090953Class IITotal Knee Surgetics Navigation System with IblockPraxim Medivision, SA / cleared 2010-01-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)