Z-0280-2025 Class II Ongoing

Recalled by Pro-Dex Inc — Irvine, CA

Recall Details

Product Type
Devices
Report Date
November 6, 2024
Initiation Date
September 23, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2000

Product Description

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

Reason for Recall

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

Distribution Pattern

US distribution to FL only.

Code Information

Lot: REF/UDI-DI: K0UB9: KLS-BP2-001/00856482008122, KLS-BP2-040/10856482008129. KLS-SD-2000/00856482008115