PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: August 28, 2019 Initiated: September 25, 2018 #Z-2340-2019

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.

Reason for Recall

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

Details

Recalling Firm
Pro-Dex Inc
Units Affected
68 cases of 40 batteries = 2,720 individual batteries
Distribution
Worldwide distribution - US Nationwide distributed in the states of CA, FL, MI, and TX, country of Finland.
Location
Irvine, CA

Frequently Asked Questions

What product 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.. Recalled by Pro-Dex Inc. Units affected: 68 cases of 40 batteries = 2,720 individual batteries.
Why was this product recalled? ▼
Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 28, 2019. Severity: Moderate. Recall number: Z-2340-2019.

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