FDA-Device2015-12-16Class II
RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
BioHorizons Implant Systems Inc
Hazard
An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.
Sold states
Worldwide Distribution - US including CA, CO, NY, OH, WA, AZ MI, MD, GA, NC, and Internationally to Iran.
Affected count
32 units
Manufactured in
2300 Riverchase Ctr, N/A, Hoover, AL, United States
Products
RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0391-2016Don't want to check this manually?
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