Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Reason: Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the thread height of the screws is undersized.

Code information: Titanium Low Profile Neuro Screw, Self-Drilling, 3mm, part number # 400.833, Lot numbers: 9960359, 9962300, 9967875

Distribution pattern: Worldwide Distribution - US Nationwide in the states of MA, VA, TN, GA, WA, IA, NJ, TN, PA, NY, CO, CT, VT, and the countries of Canada and Switzerland.