Recall Z-1438-2010 ยท HWC Screw, Fixation, Bone
Trilliant Surgical LTD
2.0/2.4 Cannulated Screw Driver Bit, part #210-24-003
| Date | Apr 26, 2010 (initiated Apr 14, 2009) |
| Status | Terminated |
| Reason | Firm received several complaints of field failures, e.g., "broke during surgery" and the firm initiated a design change. A communication to sales staff 04/14/2009 instructed them to recover and reconcile these products from user physicians. |
| Root cause | Other |
| Action | Firm notified sales force by e-mail on 4/14/2009 of the need to recover and reconcile this product . Additional documentation is not available from the firm. Questions may be directed directly to the firm at 800-495-2919. |
| Quantity | 32 units |
| Distribution | WI, TX, MO, NM, MN, OK, MA, CA, GA, ND, NE, IA, NY, LA, and MD |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081510 | TIGER CANNULATED SCREW SYSTEM Trilliant Surgical, Ltd., Aug 4, 2008 |