FDA-Device2014-02-26Class II
External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental
BioHorizons Implant Systems Inc
Hazard
The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.
Sold states
Worldwide distribution: US (nationwide) to states of: LA, CA, NC, IL, PA, and NY; and Internationally to: Seoul, Korea; New Delhi, India; Taipei City, Taiwan; and Madrid, Spain.
Affected count
119 units
Manufactured in
2300 Riverchase Center, Birmingham, AL, United States
Products
External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1058-2014Don't want to check this manually?
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