Pro-Dex Inc: Medical Device Recall in 2019 - (Recall #: Z-2340-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 25, 2018

Date Posted: August 28, 2019

Recall Number: Z-2340-2019

Event ID: 83113

Reason for Recall:

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

Status: Terminated

Product Quantity: 68 cases of 40 batteries = 2,720 individual batteries

Code Information:

PDBP-001 Series Model: PDBP-040-2 (40ct PDBP-001-2) which are 40 count batteries. Lot(s): K098N (61900), K0B3F (62625) K098N and K0B3F are Pro-Dex lot numbers. 61900 and 62625 are the contract packager's lot numbers UDI Code: (01) 0 0860540 00025 6

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated