Recall Z-2340-2019— Pro-Dex Inc

Class II FDA medical device recall by Pro-Dex Inc, initiated 2018-09-25, terminated 2022-04-20. FDA's recall record names no specific 510(k) clearance for this event. 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: Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers..

Recalling firm

Pro-Dex Inc

Classification

Class II

Status

Terminated

Initiated

2018-09-25

Terminated

2022-04-20

Firm location

Irvine, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.