Medical device recalls Moderate risk

Pro-Dex Inc recalls KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin M…

Recall date
September 23, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0280-2025
FDA classification
Class II
Brand / firm
Pro-Dex Inc
Sold / distributed
US distribution to FL only.

Why it was recalled

The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000

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