Recall Z-1430-2010 ยท HTW Bit, Drill
Orthohelix Surgical Designs Inc
Mini Max Torque 2.6 mm diameter Drill Bit, Model #HCS-072-26 & 3.8 mm Countersink, Model # HCS-070-38. Used to drill or cut bone prior to implantation of screws
| Date | Apr 22, 2010 (initiated Sep 3, 2009) |
| Status | Terminated |
| Reason | The epoxy is flaking off the drill bits and countersinks. |
| Root cause | Nonconforming Material/Component |
| Action | On 9/3/2009 the firm sent letters to their customers requesting return of all recalled product in stock and for those products to be replaced with the ones listed in the letter. Questions should be directed to 330-869-0625. |
| Quantity | 74 pieces |
| Distribution | Nationwide Distribution -- CO, OH, PA, SD, TX & VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082574 | MAXTORQUE MINI CANNULATED SCREW SYSTEM Orthohelix Surgical Designs, Inc., Dec 8, 2008 |