QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, for use on the cranium

Reason: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

Code information: 1000230170, 1000235431, 1000265421

Distribution pattern: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.