FDA Recall
Terminated
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
Recall: Z-2679-2014
·
Initiated April 25, 2013
Recall
- Recall Number
- Z-2679-2014
- Event Number
- 67727
- Firm
- Instratek, Incorporated 15200 Middlebrook Dr Ste G Houston TX 77058-1216
- FEI Number
- 1000118334
- Product Code
- HWC
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- April 25, 2013
- Posted
- September 22, 2014
- Terminated
- January 26, 2016
Description
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
Reason
Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set.
Action
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.
Distribution
Nationwide: Maine, Oregon, Florida, Texas, Virginia, Arizona, Nebraska, California, Ohio, Illinois, Oklahoma, Washington, North Carolina, Arkansas, Tennessee, New Mexico, Connecticut, Colorado
Quantity
96