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Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (b...

FDA Recall #Z-1095-2016 — Class II — December 23, 2015

Recall #Z-1095-2016 Date: December 23, 2015 Classification: Class II Status: Terminated

Product Description

Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

Reason for Recall

The sterile battery may contain particulates within the sterile package.

Recalling Firm

Pro-Dex Inc — Irvine, CA

Classification

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

Product Type

Devices

Product Quantity

1995 total

Distribution

Distributed in FL.

Code Information

Lots 509567, K055R

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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