FDA recall Z-2098-2023

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

Reason for recall

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.

Distribution

US: FL

Key facts

Status

Ongoing

Initiation date

2023-02-15

Report date

2023-07-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2098-2023