Clariance Inc recalls Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws -

Recalled July 24, 2019 · FDA recall Z-1986-2019 · Clariance

Hazard

Potential for the polyaxial screw to become disassembled during implant. · FDA Class III

Units

4,090 units distributed in the US

Sold at

Nationwide distribution to CA, IL, IN, NY, OH, TX.

Description

Potential for the polyaxial screw to become disassembled during implant.

Product

Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Erisma-LP Screwdriver; 3. Erisma-LP T20 Wrench; 4. Erisma-LPT20 Snap Fit Tightening Wrench

Manufacturer(s)

Clariance Inc

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