Agency classClass IIOur severity:High FDA (Devices)·Z-1094-2016·Announced 2016-03-23

Pro-Dex Recalls Sterile Battery Packs for Surgical Screwdrivers

Pro-Dex Inc is recalling sterile battery packs for the KLS Martin Max Driver because they may contain particulates within the sterile package.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a sterile medical device with a potential contamination hazard (particulates) that could lead to patient harm, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Pro-Dex Inc is recalling 1,995 units of the KLS-SD-1000 Battery Pack (Model KLS-BP-040). These sterile battery packs are used to power the KLS Martin Max Driver, a battery-powered surgical screwdriver. The recall involves Lots 509567 and K055R, which were distributed in Florida.

The recall was initiated because the sterile battery packs may contain particulates within the sterile package. The presence of particulates in a sterile medical device package poses a risk of contamination during surgical procedures.

Consumers and healthcare facilities should stop using the affected battery packs immediately. Users should contact Pro-Dex Inc for further instructions on how to return or dispose of the recalled products.

The recalled product

Product: Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
Manufacturer: Pro-Dex Inc
Category: Medical Device — Surgical Instrument Accessories
Hazard: contamination
particulates
Affected units: 1,995

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lots 509567
K055R

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Pro-Dex Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Pro-Dex Inc

See all →

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Pro-Dex Recalls Battery Packs for Surgical Screwdriver Due to Particulates
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Same hazard · contamination