AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw materia...

FDA Device Recall #Z-2539-2018 — Class II — May 2, 2018

Recall Summary

Recall Number Z-2539-2018
Classification Class II — Moderate risk
Date Initiated May 2, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ad-Tech Medical Instrument Corporation
Location Oak Creek, WI
Product Type Devices
Quantity 65 Total

Product Description

AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from vendor 00-0001062., AD0021502, AD0021628. Product Usage: The drill sleeve guides are accessories to the Ad-Tech Cranial Drill Bits. The Cranial Drill Bits and accessories are intended to be used for drilling holes in the skull for neurological procedures, such as brain biopsy, brain contacting electrode and electrode accessory device placement. The DSG-6.3-090-2.4N drill sleeve guides are intended to be used with the 2.4mm Cranial Drill Bit diameter.

Reason for Recall

The diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.

Distribution Pattern

US Nationwide distribution in the states of CA, FL, IL, MI, NH, NY, OH, OR, PA, SC, UT, WV. Worldwide distribution to Canada, Denmark, Germany, India, Israel, Japan, Russia, South Korea, Taiwan, United Kingdom.

Lot / Code Information

Catalog Number DSG-6.3-090-2.4N. Batch Number (Lot Number): 107104 (710220), 114390 (715001), 111423 (716180), 105176 (613121), 113775 (719190), 115847 (712211), 113776 (719190), 115000 (714201), 114724 (711101), 116389 (712121), 117146 (810110).

Other Recalls from Ad-Tech Medical Instrument Corporation

Recall # Classification Product Date
Z-0219-2025 Class II AD-TECH Spencer Probe Depth Electrode, REF SD04... Sep 19, 2024
Z-0220-2025 Class II AD-TECH Spencer Probe Depth Electrode, REF SD06... Sep 19, 2024
Z-0221-2025 Class II AD-TECH Spencer Probe Depth Electrode, REF SD08... Sep 19, 2024
Z-2495-2021 Class II Ad-Tech Lightweight TECH ATTACH Cable - Product... Aug 9, 2021
Z-2496-2021 Class II Ad-Tech TECH ATTACH Cable- Product Usage: Desig... Aug 9, 2021

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.