Recall Z-2456-2015— Trilliant Surgical Ltd.

Name: FDA recall Z-2456-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-20

Class II · Terminated

Class II FDA medical device recall by Trilliant Surgical Ltd., initiated 2015-07-20, terminated 2017-01-26. It names one FDA 510(k) clearance: K121452. Product: 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.. Reason: The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through..

Recalling firm: Trilliant Surgical Ltd.
Classification: Class II
Status: Terminated
Initiated: 2015-07-20
Terminated: 2017-01-26
Firm location: Houston, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K121452 — GRIDLOCK PLATING SYSTEMTrilliant Surgical, Ltd.·cleared 2012-08-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through.

Data sourced from openFDA. This site is unofficial and independent of the FDA.