KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040… recallZ-2098-2023 · Pro-Dex Inc · initiated Feb 15, 2023
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
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.
FDA root cause category: Error in labeling
What the company is doing
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.
Recall details
- Recall number
- Z-2098-2023
- Status
- Open, Classified
- Initiated by the company
- Feb 15, 2023
- Posted by the FDA
- Jul 5, 2023
- Recalling firm
- Pro-Dex Inc
- Quantity
- 2000
- Product code
- GEY
- Distribution
- US: FL
Product description
KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver
Code information (models, lots, serial numbers)
REF: KLS-BP-001/KLS-BP-040, UDI-DI: 00862377000140, Lot: K0M6U, Expiration: 8/31/2024
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BATTERY PACK, KLS-SD-1000, SINGLE KLS-BP-001Pro-Dex, Inc. · Motor, Surgical Instrument, Ac-Powered1 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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