Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max D...

FDA Recall #Z-1094-2016 — Class II — December 23, 2015

Recall #Z-1094-2016 Date: December 23, 2015 Classification: Class II Status: Terminated

Product Description

Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 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