Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-2490-2015

August 06, 2015

Class II

Product summary

Firm
Trilliant Surgical Ltd.
Event
Event 71967
Status
Terminated
Classification
Class II
Quantity
28 units
Official record key
device-enforcement:Z-2490-2015

Official wording

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.

Code information: Lots: TSL002595, TSL002596, TSL002597

Distribution pattern: US Distribution to the states of : FL, OH, NJ, MN, WI, NM and CA.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification