Pro-Dex Inc: Medical Device Recall in 2024 - (Recall #: Z-0280-2025)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2024.
Data Source: FDA.
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
Product Classification:
Class II
Date Initiated: September 23, 2024
Date Posted: November 6, 2024
Recall Number: Z-0280-2025
Event ID: 95510
Reason for Recall:
The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.
Status: Ongoing
Product Quantity: 2000
Code Information:
Lot: REF/UDI-DI: K0UB9: KLS-BP2-001/00856482008122, KLS-BP2-040/10856482008129. KLS-SD-2000/00856482008115
Distribution Pattern:
US distribution to FL only.
Voluntary or Mandated:
Voluntary: Firm initiated