FDA-Device2013-06-05Class II
***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
The Anspach Effort, Inc.
Hazard
Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.
Sold states
Worldwide Distribution-USA (nationwide) including DC and the states of OH, TX, IL, CA, GA, KY, FL, WI, NC, VA, WI, MN, MD, KS, OK, PA, OR ,HI, AZ, WA, TN, AR, IA, MI, CO, LA, NJ, IN, WV, MO, AL, NY, VT, and SC and the countries of France, Canada, Great Britain, Mexico, Australia, Sweden and Netherlands.
Affected count
1,827 burrs
Manufactured in
4500 Riverside Drive, N/A, Palm Beach Gardens, FL, United States
Products
***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1377-2013Don't want to check this manually?
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