FDA-Device2019-08-28Class II

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 dr

Pro-Dex Inc
Hazard

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

Sold states
Worldwide distribution - US Nationwide distributed in the states of CA, FL, MI, and TX, country of Finland.
Affected count
68 cases of 40 batteries = 2,720 individual batteries
Manufactured in
2361 McGaw Ave, N/A, Irvine, CA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2340-2019

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