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BioHorizons Implant Systems Inc recalls RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental I
Recalled December 16, 2015 · FDA recall Z-0391-2016 · BioHorizons Implant Systems
Hazard
An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging. · FDA Class II
Units
32 units
Sold at
Worldwide Distribution - US including CA, CO, NY, OH, WA, AZ MI, MD, GA, NC, and Internationally to Iran.
Description
An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.
Product
RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
Manufacturer(s)
BioHorizons Implant Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →