Recall Z-2421-2015 ยท HWC Screw, Fixation, Bone
Trilliant Surgical Ltd.
2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE Product Usage: 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 19, 2015 (initiated Jul 20, 2015) |
| Status | Terminated |
| Reason | The cutting efficiency of the Countersinks was out of specification. |
| Root cause | Nonconforming Material/Component |
| Action | Trilliant sent an Important Medical Device Advisory Notice letter dated February 15, 2013 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers of the option to exchange affected instruments at no charge. To initiate the exchange customers were instructed to contact your local Trilliant Surgical Sales Representative, contact the Customer Service Department directly at 1-800-495-2919, or via email at orders@trilliantsurgical.com. |
| Quantity | 102 units |
| Distribution | US Nationwide Distribution in the states of: NY, CT, TN, TX, OH, IN, LA, NC, MO, MN, GA, FL, SC, WA, WI, IA, PA, CA, ND, OK, NJ, MI 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 |