Z-2490-2015 Class II Terminated
FDA device recall Z-2490-2015 was initiated by Trilliant Surgical Ltd. on August 6, 2015 and is designated Class II. 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 insufficie… The recall status is terminated (terminated January 26, 2017). Affected quantity: 28 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2015
- Initiation Date
- August 6, 2015
- Termination Date
- January 26, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 units
Product Description
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.
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 Pattern
US Distribution to the states of : FL, OH, NJ, MN, WI, NM and CA.
Code Information
Lots: TSL002595, TSL002596, TSL002597