Recall Z-2539-2018 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Ad-Tech Medical Instrument Corporation
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 a
| Date | May 2, 2018 |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | Customers were notified on 05/02/2018 via a MEDICAL DEVICE RECALL letter. Instructions included to immediately examine your inventory and quarantine any product subject to recall and replacement. Customers/distributors who received affected devices will be contacted to return their unopened/unused and/or reused stock of the affected product. |
| 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. |
| 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 |