FDA-Device2015-05-20Class II
Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
BioHorizons Implant Systems Inc
Hazard
BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium.
Sold states
US Nationwide in the states of: AL, FL, MS, VA, LA, CA, NC, TX, TN, OH, OK, VT, WA, MD, NY, SD, and SC.
Affected count
48 units
Manufactured in
2300 Riverchase Ctr, N/A, Hoover, AL, United States
Products
Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1605-2015Don't want to check this manually?
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