Recall Z-2679-2014 ยท HWC Screw, Fixation, Bone
Instratek, Incorporated
Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System
| Date | Sep 22, 2014 (initiated Apr 25, 2013) |
| Status | Terminated |
| Reason | Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set. |
| Root cause | Nonconforming Material/Component |
| Action | The firm plans to notify their customers of the recall via email, telephone and visit. The firm then plans to scrap and discard any affected product. |
| Quantity | 96 |
| Distribution | Nationwide: Maine, Oregon, Florida, Texas, Virginia, Arizona, Nebraska, California, Ohio, Illinois, Oklahoma, Washington, North Carolina, Arkansas, Tennessee, New Mexico, Connecticut, Colorado |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120493 | MINI CANNULATED HEADED AND HEADLESS SCREW SET Instratek, Inc., May 17, 2012 |