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Open, Classified

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

FDA Recall Z-0280-2025 · Posted 2024-10-31

Recalling FirmPro-Dex Inc
Recall StatusOpen, Classified
Product CodeMOQ
Date Initiated2024-09-23
Product Quantity2000

Reason for Recall

The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.

Firm Action

On 9/23/24, an "URGENT" recall notice was emailed to the customer informing of the product, issue, risk and actions to be taken. Customers were instructed to do the following: 1) Please immediately cease distribution and use of these lots. Inventory and distribution records should be evaluated to ensure that affected product is removed from any potential point of use. 2) Product should be returned to the recalling firm. 3) The Recall Acknowledgement and Return Form should be completed and returned via email to [email protected] or FAX 949.769.3281. Questions or concerns can be directed to the firm at 949-769-3200 or [email protected]

Root Cause

Component design/selection

Distribution Pattern

US distribution to FL only.

Official Source

View FDA Recall →

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

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