Device product
KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver
Z-2098-2023
Product summary
- Firm
- Pro-Dex Inc
- Event
- Event 92493
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2000
- Official record key
device-enforcement:Z-2098-2023
Official wording
Reason: Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch labels, so batteries will appear to be prematurely expired.
Code information: REF: KLS-BP-001/KLS-BP-040, UDI-DI: 00862377000140, Lot: K0M6U, Expiration: 8/31/2024
Distribution pattern: US: FL
Derived failure modes
-
Unknown
Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch labels, so batteries will appear to be prematurely expired.