# FDA recall Z-2539-2018

> **Ad-Tech Medical Instrument Corporation** · Class II · device recall initiated 2018-05-02.

## Product

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

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.

## Key facts

- **Recall number:** Z-2539-2018
- **Recalling firm:** Ad-Tech Medical Instrument Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-02
- **Report date:** 2018-08-01
- **Termination date:** 2019-02-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Oak Creek, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2539-2018

## Citation

> AI Analytics. FDA recall Z-2539-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2539-2018. Source: US FDA. Licensed CC0.

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