KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040… recallZ-0280-2025 · Pro-Dex Inc · initiated Sep 23, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Pro-Dex Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.
FDA root cause category: Component design/selection
What the company is doing
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]
Recall details
- Recall number
- Z-0280-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 23, 2024
- Posted by the FDA
- Oct 31, 2024
- Recalling firm
- Pro-Dex Inc
- Quantity
- 2000
- Product code
- MOQ
- Distribution
- US distribution to FL only.
Product description
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
Code information (models, lots, serial numbers)
Lot: REF/UDI-DI: K0UB9: KLS-BP2-001/00856482008122, KLS-BP2-040/10856482008129. KLS-SD-2000/00856482008115
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- KLS MaxDriver 2 KLS-SD-2000Pro-Dex, Inc. · Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment1 recall0 reports
- BATTERY PACK, KLS-SD-2000, SINGLE KLS-BP2-001Pro-Dex, Inc. · Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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