Class II — Ad-Tech Medical Instrument Corporation
| Recalling firm | AD-TECH MEDICAL INSTRUMENT CORP. |
|---|---|
| Registered facility | AD-TECH MEDICAL INSTRUMENT CORP. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 65 Total |
| 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. |
| Initiated | 2018-05-02 |
| Classified | 2018-07-25 |
| Terminated | 2019-02-08 |
| Recall number | Z-2539-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ad-Tech Medical Instrument Corporation (Z-2539-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80280/
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