Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System
This recall has been terminated (originally issued September 22, 2014).
- Recall Initiated
- April 25, 2013
- Posted
- September 22, 2014
- Terminated
- January 26, 2016
- Recall Number
- Z-2679-2014
- Quantity
- 96
- Official Source
- View on FDA website ↗
Reason for Recall
Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set.
Distribution
Nationwide: Maine, Oregon, Florida, Texas, Virginia, Arizona, Nebraska, California, Ohio, Illinois, Oklahoma, Washington, North Carolina, Arkansas, Tennessee, New Mexico, Connecticut, Colorado
Lot / Code Info
Mini System part no. IS1100 - lot 0001-0047; Instrument part nos. IS1103, IS1104, and IS1105 - lots 918101, 918102, and 918103
Root Cause
Nonconforming Material/Component
Action Taken
The firm plans to notify their customers of the recall via email, telephone and visit. The firm then plans to scrap and discard any affected product.