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 inner 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 Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N |
| Quantity | 315 units |
| Distribution | NY, PA, WI, AZ, IL, CA, NH, GA, MA, MN, UT, MI, WA, FL, TX, OH, OR, PA, MD, and India, Korea, Taiwan, Canada, Hong Kong, Denmark, Russia, Singapore, Japan, Brazil. UK, Spain, Czech Republic, France |
| Initiated | 2019-08-27 |
| Classified | 2019-09-13 |
| Terminated | 2023-04-05 |
| Recall number | Z-2544-2019 |
| 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-2544-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83628/
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