Z-2456-2015 Class II Terminated

Recalled by Trilliant Surgical Ltd. — Houston, TX

Recall Details

Product Type
Devices
Report Date
September 2, 2015
Initiation Date
July 20, 2015
Termination Date
January 26, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
638 units

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.

Distribution Pattern

Nationwide throughout the US

Code Information

TSL000145, TSL000162, TSL000699, TSL000146, TSL000163, TSL000700, TSL00147, TSL000164, TSL000701, TSL000702, TSL000148, TSL000165, TSL000706, TSL000149, TSL000166, TSL000688, TSL000150, TSL000167, TSL000707, TSL000708