Pro-Dex

6 recalls •

• Categories: Surgical Instruments, Infusion Pumps

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

Class I - Dangerous

The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.

Sep 23, 2024 Surgical Instruments View Details →

KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver

Class I - Dangerous

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.

Feb 15, 2023 Infusion Pumps View Details →

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.

Class I - Dangerous

Incorrect Unique Device Identifier/GTIN code was used on product.

Feb 14, 2023 Infusion Pumps Nationwide View Details →

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.

Class I - Dangerous

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

Sep 25, 2018 Surgical Instruments Nationwide View Details →

Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

Class I - Dangerous

The sterile battery may contain particulates within the sterile package.

Dec 23, 2015 Surgical Instruments View Details →

Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

Class I - Dangerous

The sterile battery may contain particulates within the sterile package.

Dec 23, 2015 Surgical Instruments View Details →