Z-2340-2019Class II

PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX...

Name: Z-2340-2019 PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX...
Creator: Pro-Dex Inc
Published: 2018-09-25
License: https://open.fda.gov/license/

Pro-Dex Inc / initiated 2018-09-25 / Terminated / root cause: packaging

FDA source

Pro-Dex Inc began a recall of 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... on 2018-09-25. FDA classified it as Class II and gives the reason as "Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2340-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-25
Posted: 2019-08-22
Terminated: 2022-04-20
Recalling firm: Pro-Dex Inc
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.
Product code: GEY Motor, Surgical Instrument, Ac-Powered
Reason for recall: Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: On 09/25/2018, the firm sent an "URGENT" notification to customers via email and followed up with a (USPS) letter on 09/26/2018 informing them that certain lots of sterile batteries may have visible particulates within the battery Tyvek pouch. Customers were advised to 1) "immediately cease distribution and use of these lots, and 2) Inventory and distribution records should be evaluated immediately to ensure that affected product is removed from any potential point of use". Customers are instructed to return products to: Returns Department (Recall complaint C18-061 Pro-Dex, Inc. 2361 McGaw Avenue Irvine, CA 92614 USA and to reference the Recall Complaint #C18-061 on the outside of the shipping box. If the customers have any questions or concerns to contact the QARA group at 949 769 3200.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2340-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2340-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22

Product code GEY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)