FDAClass IIFebruary 20, 2019

OMNI K1 Broach Handle recall

OMNI K1 Broach Handle, Product Code HS-10054

Why was OMNI K1 Broach Handle recalled?

There is a potential for the inner pin of the handle to become loose and fall out.

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 MM0118

Product
OMNI K1 Broach Handle, Product Code HS-10054
Recalling firm
OMNIlife science Inc.
Quantity
7
Distribution
The products were distributed to the following US states: CA, GA, SC, and UT.
Recall date
February 20, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls