FDA-Device2015-09-02Class II
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.
Trilliant Surgical Ltd.
Hazard
The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through.
Sold states
Nationwide throughout the US
Affected count
638 units
Manufactured in
6721 Portwest Dr Ste 160, N/A, Houston, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2456-2015Don't want to check this manually?
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