Synthes (USA) Products LLC: Medical Device Recall in 2016 - (Recall #: Z-1326-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 23, 2016

Date Posted: April 13, 2016

Recall Number: Z-1326-2016

Event ID: 73561

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.

Status: Terminated

Product Quantity: 500 units distributed in USA, and 35 units distributed OUS

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.

Voluntary or Mandated:

Voluntary: Firm initiated