medical Class III Updated 2019-07-24

Clariance Inc recalls Erisma- LP posterior fixation system with the below specific

Recalled 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


Hazard / Issue

Potential for the polyaxial screw to become disassembled during implant.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 1. Catalog Numbers: 181545XX, 181555XX, 181565XX, 181575XX, 181585XX, 181595XX, 181510XX; 2. Catalog Number 18710024; 3. Catalog Number 18720000; 4. Catalog Number 01720001
View official government recall

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