Pro-Dex Inc recalls PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pa…

Recall date

September 25, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2340-2019

FDA classification

Class II

Brand / firm

Pro-Dex Inc

Sold / distributed

Worldwide distribution - US Nationwide distributed in the states of CA, FL, MI, and TX, country of Finland.

Why it was recalled

Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.

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

What was recalled

PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery.