CLASS II Device recall · Reported 28 Aug 2019 · FDA Enforcement Report

Surgical Driver Battery Pack Pdbp-001 Series Pro-dex recalled

Pro-Dex is recalling Surgical Driver Battery Pack Pdbp-001 Series Pro-dex Battery Pack, Single Pouch, distributed nationwide in the US. The recall was initiated on 25 Sep 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPDBP-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

Quantity recalled68 cases of 40 batteries = 2,720 individual batteries

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2340-2019
FDA event ID: 83113
Recalling firm: Pro-Dex, Irvine, CA
Classification: Class II
Status: Terminated
Recall initiated: 25 Sep 2018
FDA classified: 22 Aug 2019
Reported: 28 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Device type: Surgical Instruments

Timeline

25 Sep 2018	Recall initiated by company
22 Aug 2019	Classified by FDA	+331 days
28 Aug 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

Worldwide distribution - US Nationwide distributed in the states of CA, FL, MI, and TX, country of Finland.

Nationwide California Florida Michigan Texas

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Worldwide distribution - US Nationwide distributed in the states of CA, FL, MI, and TX, country of Finland.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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