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
Z-0280-2025
Product summary
- Firm
- Pro-Dex Inc
- Event
- Event 95510
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2000
- Official record key
device-enforcement:Z-0280-2025
Official wording
Reason: The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.
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.
Derived failure modes
-
Unknown
The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.