Device product
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
Z-2679-2014
Product summary
- Event
- Event 67727
- Status
- Terminated
- Classification
- Class II
- Quantity
- 96
- Official record key
device-enforcement:Z-2679-2014
Official wording
Reason: Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set.
Code information: Mini System part no. IS1100 - lot 0001-0047; Instrument part nos. IS1103, IS1104, and IS1105 - lots 918101, 918102, and 918103
Distribution pattern: Nationwide: Maine, Oregon, Florida, Texas, Virginia, Arizona, Nebraska, California, Ohio, Illinois, Oklahoma, Washington, North Carolina, Arkansas, Tennessee, New Mexico, Connecticut, Colorado
Derived failure modes
-
Unknown
Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set.