FDA recall Z-2340-2019

Pro-Dex Inc · Class II · device

Product

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.

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2018-09-25
Report date
2019-08-28
Termination date
2022-04-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irvine, CA, United States

Primary source

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