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Open, Classified

KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver

FDA Recall Z-2098-2023 · Posted 2023-07-05

Recalling FirmPro-Dex Inc
Recall StatusOpen, Classified
Product CodeGEY
Date Initiated2023-02-15
Product Quantity2000

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.

Firm Action

On 2/15/23, a recall notice was sent to a customer asking them to cease distribution and return affected product to the recalling firm. Questions can be directed to 949-769-3200.

Root Cause

Error in labeling

Distribution Pattern

US: FL

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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