SpineFrontier, Inc. recalls InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instrum

Recalled July 10, 2013 · FDA recall Z-1666-2013 · SpineFrontier

Hazard

Potential for set screw to be come deformed. · FDA Class II

Units

61 individual inserter assemblies

Sold at

Worldwide Distribution - USA Nationwide: in the states of: FL, CO, VA, KS, TX, OH, TN, OK, CA, IL, MO, MN, Wash DC, including PR and the countries of Dominican Republic, Medico, Panama

Description

Potential for set screw to be come deformed.

Product

InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to install the InSpan Spinous Plate System for the purpose of achieving supplemental fixation.

Manufacturer(s)

SpineFrontier, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →