FDAClass IIINovember 23, 2016

OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE recall

OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic…

Why was OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE recalled?

Incorrect lot number on outer kit

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot number: 19-09-021

Product
OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic…
Recalling firm
OMNI LIFE SCIENCE
Quantity
15 units
Distribution
Worldwide Distribution: US distribution to OK, MD, TX and country of: Australia.
Recall date
November 23, 2016
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls