Recall Z-2456-2015 ยท HTO Reamer
Trilliant Surgical Ltd.
Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm; Convex Reamer Head, 18 mm; Convex Reamer Head 20 mm; Convex Reamer Head 22 mm, used with Gridlock Plating system, for use in trauma and reconstructive procedures in small bones.
| Date | Aug 24, 2015 (initiated Jul 20, 2015) |
| Status | Terminated |
| Reason | The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through. |
| Root cause | Component design/selection |
| Action | The recalling firm sent out written notification of the recall on 7/3/14. The letter instructed the consignees to exchange affected instruments. |
| Quantity | 638 units |
| Distribution | Nationwide throughout the US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121452 | GRIDLOCK PLATING SYSTEM Trilliant Surgical, Ltd., Aug 20, 2012 |