KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to co...

FDA Device Recall #Z-1391-2023 — Class II — February 14, 2023

Recall Summary

Recall Number Z-1391-2023
Classification Class II — Moderate risk
Date Initiated February 14, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Pro-Dex Inc
Location Irvine, CA
Product Type Devices
Quantity 199 devices

Product Description

KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.

Reason for Recall

Incorrect Unique Device Identifier/GTIN code was used on product.

Distribution Pattern

U.S. Nationwide distribution in the state of FL.

Lot / Code Information

Reference Number: PDEC-1000-2 Part Number: A9671 Lot Numbers: K0C1B, K0D3P, K0E8T, K0FSD, K0HGV

Other Recalls from Pro-Dex Inc

Recall # Classification Product Date
Z-0280-2025 Class II KLS Martin Battery Pack, REF: KLS BP2 001, and ... Sep 23, 2024
Z-2098-2023 Class II KLS Martin Battery Pack, REF: KLS BP 001, and K... Feb 15, 2023
Z-2340-2019 Class II PRO-DEX Surgical Driver Battery Pack PDBP-001 S... Sep 25, 2018
Z-1095-2016 Class II Battery Pack KLS-SD-1000 Single Models: KLS-... Dec 23, 2015
Z-1094-2016 Class II Battery Pack KLS-SD-1000 Case (40 ct) Models... Dec 23, 2015

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.