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Synthes (USA) Products LLC recalls Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile
Recalled April 13, 2016 · FDA recall Z-1327-2016 · Synthes (USA) Products
Hazard
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. · FDA Class II
Units
150 units distributed in US, 1439 units distributed OUS (foreign)
Sold at
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.
Description
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.
Product
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.
Manufacturer(s)
Synthes (USA) Products LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →