Synthes (USA) Products LLC recalls Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Ne…

Recall date

February 23, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1327-2016

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.