19 results
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57ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar), Biohorizons Implant Systems, Inc., Birmingham, AL 35243
FDA Recall
Terminated
·BioHorizons Implant Systems Inc One Perimeter Park South·Product code DZE·April 18, 2007
BioHorizons 0.050 Hex Driver, Regular, REF 300-350, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only
FDA Recall
Terminated
·BioHorizons Implant Systems Inc One Perimeter Park South·Product code DZE·March 12, 2007
BioHorizons 0.050 Hex Driver, Long, REF 300-351, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only
FDA Recall
Terminated
·BioHorizons Implant Systems Inc One Perimeter Park South·Product code DZE·March 12, 2007
BioHorizons 0.035 Hex Driver, REF 300-377, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only, REF 300-377.
FDA Recall
Terminated
·BioHorizons Implant Systems Inc One Perimeter Park South·Product code DZE·March 12, 2007
BioHorizons 0.050 Hex Driver, Regular, REF 134-350, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only. The product is part of a Prosthetic Instrumentation system Kit 51-K , Manufactured by Innovision, Inc., and the kits are assembled by BioHorizons.
FDA Recall
Terminated
·BioHorizons Implant Systems Inc One Perimeter Park South·Product code DZE·March 12, 2007
Single-stage 3.5mm Healing Abutment, 4 mm, REF SYHA40, Rx Only, STERILE R, gamma irradiated, expires 2014-44, CE 0473, BIOHORIZONS, BIRMINGHAM, AL 35244. Endosseous dental implant healing abutment.
FDA Recall
Terminated
·BioHorizons Implant Systems Inc·Product code DZE·September 7, 2010
AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
FDA Recall
Terminated
·BioHorizons Implant Systems Inc·Product code DZE·November 19, 2012
Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
FDA Recall
Terminated
·BioHorizons Implant Systems Inc·Product code DZE·November 19, 2012
RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
FDA Recall
Terminated
·BioHorizons Implant Systems Inc·Product code DZE·October 30, 2015
Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
FDA Recall
Terminated
·BioHorizons Implant Systems Inc·Product code DZE·April 16, 2015
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
FDA Recall
Terminated
·BioHorizons Implant Systems Inc·Product code DZE·December 10, 2013
AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
FDA Enforcement
Class II
·Terminated·BioHorizons Implant Systems Inc·December 26, 2012
Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
FDA Enforcement
Class II
·Terminated·BioHorizons Implant Systems Inc·December 26, 2012
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
FDA Enforcement
Class II
·Terminated·BioHorizons Implant Systems Inc·February 26, 2014
RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
FDA Enforcement
Class II
·Terminated·BioHorizons Implant Systems Inc·December 16, 2015
Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
FDA Enforcement
Class II
·Terminated·BioHorizons Implant Systems Inc·May 20, 2015
The Maestor System 225-312, Profile Abutment for Cement, 5mm
FDA Recall
Terminated
·BioHorizons Implant Systems Inc One Perimeter Park South·Product code NDP·June 3, 2005
The Maestro System 204-503, Straight Permucosal Ext, 5mm x 3mm
FDA Recall
Terminated
·BioHorizons Implant Systems Inc One Perimeter Park South·Product code NDP·June 3, 2005
BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants and Surgical Kit
FDA Recall
Terminated
·BioHorizons Implant Systems Inc One Perimeter Park South·Product code DZE·December 28, 2005