Irvine, CA, United States
Pro-Dex Inc recalls
4 recalls recorded since 2018, most recently on 23 September 2024. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)3
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 23 September 2024
- Reason
- The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.
- Distribution
- US distribution to FL only.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0280-2025
- KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000
Ongoing Class II Medical devices
- Recall started
- 15 February 2023
- Reason
- Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch labels, so batteries will appear to be prematurely expired.
- Distribution
- US: FL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2098-2023
- KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver
Ongoing Class II Medical devices
- Recall started
- 14 February 2023
- Reason
- Incorrect Unique Device Identifier/GTIN code was used on product.
- Distribution
- U.S. Nationwide distribution in the state of FL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1391-2023
- KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.
Terminated Class II Medical devices
- Recall started
- 25 September 2018
- Terminated
- 20 April 2022
- Reason
- Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
- Distribution
- Worldwide distribution - US Nationwide distributed in the states of CA, FL, MI, and TX, country of Finland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2340-2019
- 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-rechargea
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.