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.
Z-2340-2019
Product summary
- Firm
- Pro-Dex Inc
- Event
- Event 83113
- Status
- Terminated
- Classification
- Class II
- Quantity
- 68 cases of 40 batteries = 2,720 individual batteries
- Official record key
device-enforcement:Z-2340-2019
Official wording
Reason: Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
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.
Derived failure modes
-
Foreign material or chemical contamination
particulates