Recall Z-2544-2019 ยท HBG Drills, Burrs, Trephines & Accessories (Manual)
Ad-Tech Medical Instrument Corporation
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
| Date | Aug 27, 2019 |
| 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. |
| Root cause | Under Investigation by firm |
| Action | The firm initiated the recall by letter on 08/27/2019. The firm requested the units be returned. |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170442 | Cranial Drill Bits and Accessories Ad-Tech Medical Instrument Corporation, Sep 7, 2017 |