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OMNI K1 Broach Handle, Product Code HS-10054

FDA Recall #Z-0837-2019 — Class II — November 29, 2018

Recall #Z-0837-2019 Date: November 29, 2018 Classification: Class II Status: Terminated

Product Description

OMNI K1 Broach Handle, Product Code HS-10054

Reason for Recall

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

Recalling Firm

OMNIlife science Inc. — Raynham, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

7

Distribution

The products were distributed to the following US states: CA, GA, SC, and UT.

Code Information

Lot Number MM0118

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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