# FDA recall Z-2340-2019

> **Pro-Dex Inc** · Class II · device recall initiated 2018-09-25.

## 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

- **Recall number:** Z-2340-2019
- **Recalling firm:** Pro-Dex Inc
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-2340-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2340-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*