Disposable Drill Kit which includes two drill bits — Class II medical device recall Z-1938-2018
Terminated recall by Ad-Tech Medical Instrument Corporation, reported 2018-06-06, distributed nationwide. There is a possibility that DDK2-2.4-30X Disposable Drill Kits, Lot Number 111664 208140649 contained 2.8mm dr
| Recall number | Z-1938-2018 |
|---|---|
| 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 | 2017-12-20 |
| Classified | 2018-05-25 |
| Reported by FDA | 2018-06-06 |
| Terminated | 2018-10-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GB |
| Quantity | 30 devices |
| Lot numbers | 0111664, 0111745, 208140649 |
| Model numbers | DDK2-2.4-30X, DDK2-2.8-30X |
Product
Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long and made of stainless steel. The drill kits are supplied in a sterile state and are single-use only. Used to drill cranial holes using a stereotactic frame.
Reason for recall
There is a possibility that DDK2-2.4-30X Disposable Drill Kits, Lot Number 111664 208140649 contained 2.8mm drill bits from DDK2-2.8-30X Disposable Drill Kits, Lot Number 111745 208140649 and vice versa.
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-1938-2018. 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.