Recall Z-0280-2025— Pro-Dex Inc

Name: FDA recall Z-0280-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-23

Class II · Ongoing

Class II FDA medical device recall by Pro-Dex Inc, initiated 2024-09-23. FDA's recall record names no specific 510(k) clearance for this event. 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: The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package..

Recalling firm: Pro-Dex Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-09-23
Firm location: Irvine, CA, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.