Clariance Inc recalls Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5…

Recall date

July 1, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1986-2019

FDA classification

Class III

Brand / firm

Clariance Inc

Sold / distributed

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

Why it was recalled

Potential for the polyaxial screw to become disassembled during implant.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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