FDA-Device2014-08-20Class II
Double Offset Rasp Handle, Left Hand Nonsterile
Zimmer, Inc.
Hazard
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.
Sold states
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.
Affected count
412 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Double Offset Rasp Handle, Left Hand Nonsterile
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2217-2014Don't want to check this manually?
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