AD-TECH Medical Instrument Corporation Drill Sleeve Guides… — Class II medical device recall Z-2539-2018
Terminated recall by Ad-Tech Medical Instrument Corporation, reported 2018-08-01, distributed nationwide. The diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in
| Recall number | Z-2539-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ad-Tech Medical Instrument Corporation, Oak Creek, WI, United States |
| Recall initiated | 2018-05-02 |
| Classified | 2018-07-25 |
| Reported by FDA | 2018-08-01 |
| Terminated | 2019-02-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, DK, GB, IL, IN, JP, KR, RU, TW |
| Quantity | 65 total |
| Lot numbers | 105176, 107104, 111423, 113775, 113776, 114390, 114724, 115000, 115847, 116389, 117146 |
| Model numbers | DSG-6.3-090-2.4N |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2539-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.