Recall Z-0960-2017 ยท HWC Screw, Fixation, Bone
Trilliant Surgical Ltd.
Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.
| Date | Jan 6, 2017 (initiated Dec 8, 2016) |
| Status | Terminated |
| Reason | Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a printing error where k-wire description markings indicate diameters of 0.45 and 0.35 instead of 0.045" and 0.035", respectively. |
| Root cause | Under Investigation by firm |
| Action | Trilliant Surgical Ltd. sent an Urgent Medical Device Recall letter dated December 8, 2016, to all affected consignees. The letter instructed the consignees to 1) identify any/all affected product; 2) document any/all identified product via a provided response form and return to Trilliant Surgical; 3) exchange product upon receipt of replacements; and 4) return any/all affected product as originally identified and reported on the return response form. Customers with questions were instructed to call 800-495-2919. |
| Quantity | 50 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153338 | Tiger Cannulated Screw System Trilliant Surgical, Ltd., Jan 14, 2016 |