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.
This recall has been terminated (originally issued August 24, 2015).
- Company
- Trilliant Surgical Ltd.
- Recall Initiated
- July 20, 2015
- Posted
- August 24, 2015
- Terminated
- January 26, 2017
- Recall Number
- Z-2456-2015
- Quantity
- 638 units
- Firm Location
- Houston, TX
- Official Source
- View on FDA website ↗
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
Nationwide throughout the US
Lot / Code Info
TSL000145, TSL000162, TSL000699, TSL000146, TSL000163, TSL000700, TSL00147, TSL000164, TSL000701, TSL000702, TSL000148, TSL000165, TSL000706, TSL000149, TSL000166, TSL000688, TSL000150, TSL000167, TSL000707, TSL000708
Root Cause
Component design/selection
Action Taken
The recalling firm sent out written notification of the recall on 7/3/14. The letter instructed the consignees to exchange affected instruments.
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