Z-0610-2017Class III

OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now...

Name: Z-0610-2017 OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now...
Creator: Omni Life Science
Published: 2016-10-14
License: https://open.fda.gov/license/

Omni Life Science, Inc. / initiated 2016-10-14 / Terminated / root cause: labeling and UDI

FDA source

OMNI LIFE SCIENCE began a recall of OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery... on 2016-10-14. FDA classified it as Class III and gives the reason as "Incorrect lot number on outer kit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0610-2017
Classification: Class III
Status: Terminated
Initiated: 2016-10-14
Posted: 2016-11-17
Terminated: 2017-02-01
Recalling firm: Omni Life Science, Inc.
Product: OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: Total Knee Arthroplasty
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Incorrect lot number on outer kit
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm, OMNIlife Science, Inc., issued an "URGENT MEDICAL DEVICE ADVISORY NOTICE" dated 10/14/16 by email to its consignees/customers. U.S. and foreign agents were also sent the notification packet via overnight mail. Acknowledgement of receipt is requested. The notice described the product, problem and actions to be taken. The customers were instructed to immediately quarantine lot 19-09-021 for OMNIBotics Tracker Kit RM-1000; overlabel the outside packaging with the label provided following the provided training paperwork and rework instructions; note advisory notice only includes listed product, it does not affect other lots; and complete and return the Acknowledgement and Receipt Form and accompanying FN-102 by Fax to 508-519-3390. Accounts are to hold item RM-10000 with the lot # 19-09-021 until a corrected label is provided for the outer box. The patient labels inside the box are correct. For further information , Regulatory Affairs Specialist at 774-226-1847 or 800-448-6664 Monday through Friday, 8:00 AM to 4:30 PM, Easter Time.
Quantity in commerce: 15 units
Distribution: Worldwide Distribution: US distribution to OK, MD, TX and country of: Australia.
Product codes and lots: Lot number: 19-09-021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0610-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0610-2017	Class III	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-17

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)