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.
This recall has been terminated (originally issued August 31, 2015).
- Company
- Trilliant Surgical Ltd.
- Recall Initiated
- August 6, 2015
- Posted
- August 31, 2015
- Terminated
- January 26, 2017
- Recall Number
- Z-2490-2015
- Quantity
- 28 units
- Firm Location
- Houston, TX
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Distribution to the states of : FL, OH, NJ, MN, WI, NM and CA.
Lot / Code Info
Lots: TSL002595, TSL002596, TSL002597
Root Cause
Nonconforming Material/Component
Action Taken
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