FDA-Device2019-07-24Class III
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
Clariance Inc
Hazard
Potential for the polyaxial screw to become disassembled during implant.
Sold states
Nationwide distribution to CA, IL, IN, NY, OH, TX.
Affected count
4,090 units distributed in the US
Manufactured in
4809 N Ravenswood Ave Unit 119, N/A, Chicago, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1986-2019Don't want to check this manually?
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