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BioHorizons Implant Systems Inc recalls External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Cent
Recalled February 26, 2014 · FDA recall Z-1058-2014 · BioHorizons Implant Systems
Hazard
The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length. · FDA Class II
Units
119 units
Sold at
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.
Description
The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.
Product
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
Manufacturer(s)
BioHorizons Implant Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →