Recall Z-2490-2015 ยท HRS Plate, Fixation, Bone
Trilliant Surgical Ltd.
7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERILE SINGLE USE ONLY; 11 Hole VL Gridlock Fibula Plate, Part # 300-60-003 NON-STERILE SINGLE USE ONLY. For use in trauma and reconstructive procedures in small bones.
| Date | Aug 31, 2015 (initiated Aug 6, 2015) |
| Status | Terminated |
| Reason | The affected parts subject to the recall are out of specification, resulting in in the loss of the optimal locking screw functionality of the plates. The thread depth of the screw holes is insufficient, potentially limiting the ability to engage and lock with associated mating locking screws. |
| Root cause | Nonconforming Material/Component |
| Action | Trilliant Surgical sent an Urgent Medical Device Recall letter dated August 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed and confirmed consignees to discontinue use of the affected lots, quarantine, and return product (if not yet done so) in accordance with an included acknowledgement sheet. For further questions, please call 1(800) 495-2919 , 8:00am - 5:00pm CST |
| Quantity | 28 units |
| Distribution | US Distribution to the states of : FL, OH, NJ, MN, WI, NM and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121452 | GRIDLOCK PLATING SYSTEM Trilliant Surgical, Ltd., Aug 20, 2012 |