Vl DBL OFFST WI LRG STPL, RT Nonsterile

Reason: The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

Code information: Item Number 82016757942 Lot Number 97009220, 97009255, 97009256, 97009585

Distribution pattern: Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.