PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: April 13, 2016 Initiated: February 23, 2016 #Z-1326-2016

Product Description

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 for Recall

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.

Details

Units Affected
500 units distributed in USA, and 35 units distributed OUS
Distribution
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.
Location
West Chester, PA

Frequently Asked Questions

What product 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.. Recalled by Synthes (USA) Products LLC. Units affected: 500 units distributed in USA, and 35 units distributed OUS.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 13, 2016. Severity: Moderate. Recall number: Z-1326-2016.

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