FDA recall Z-0280-2025

Pro-Dex Inc · Class II · device

Product

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

US distribution to FL only.

Key facts

Status: Ongoing
Initiation date: 2024-09-23
Report date: 2024-11-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0280-2025