Recall Z-2464-2015 ยท HWC Screw, Fixation, Bone
Trilliant Surgical Ltd.
Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are components of the Tiger Cannulated Screw System and the Tiger Headless Cannulated Screw System The Tiger Cannulated Screw Fixation System and the Tiger Headless Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and
| Date | Aug 26, 2015 (initiated Jul 20, 2015) |
| Status | Terminated |
| Reason | Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported to occasionally be difficult to remove from the sterilization tray. |
| Root cause | Component design/selection |
| Action | Trilliant sent an Important Medical Device Adivsory Notice dated November 6, 2013, to all affected customers. The letter instructed customers that they have the option of exchanging affected instruments for trays that meet specification at no charge. To initiate the exchange, customers were instructed to contact their local Trilliant Surgical sales representative or the Customer Service Department directly at 1-800-495-2919, or via email at orders@trilliantsurgical.com. |
| Quantity | 71 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |