Recall Z-2452-2015 ยท HTW Bit, Drill
Trilliant Surgical Ltd.
3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only.
| Date | Aug 24, 2015 (initiated Jul 20, 2015) |
| Status | Terminated |
| Reason | The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through. |
| Root cause | Nonconforming Material/Component |
| Action | Trilliant Surgical sent an Important Medical Device Advisory Notice to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Customers were instructed they have the option to exchange the affected drill bits at no charge. To initiate the exchange, customers were instructed to contact their local Trilliant Surgical Sales Representative or contact the Customer Service Department directly at 1-800-495-2919 or via email at orders@trilliantsurgical.com. |
| Quantity | 121 units |
| Distribution | Nationwide Distribution including NY, TX, OH, IN, FL, NH, MN, SC, OK, NJ, CA, NC, MO, GA, WI, IA, TN, WA, and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081510 | TIGER CANNULATED SCREW SYSTEM Trilliant Surgical, Ltd., Aug 4, 2008 |