FDAJuly 1, 2019device
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 recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential for the polyaxial screw to become disassembled during implant.
What to do
FDA enforcement status: Terminated
Brands named
clariance
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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