Biohorizons Implant Systems
FDA adverse event reports naming Biohorizons Implant Systems as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: BIOHORIZONS IMPLANT SYSTEMS.
- Total reports
- 57,913
- Deaths
- 0
- Injuries
- 57,537
- Malfunctions
- 376
Reports per year
Source: FDA adverse event reports by year received, 2019–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
Recent recalls
- 2015-12-07TerminatedEmployee error
RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.
- 2015-05-12TerminatedProcess control
Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium.
- 2014-02-20TerminatedMixed-up of materials/components
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
The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.
- 2012-12-19TerminatedComponent design/selection
AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.
- 2012-12-19TerminatedComponent design/selection
Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.
- 2010-11-04TerminatedOther
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.
Healing abutment may not fully seat on the implant.
- 2007-05-11TerminatedOther
Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar), Biohorizons Implant Systems, Inc., Birmingham, AL 35243
Dental implant system is missing ball attachment system.
- 2007-04-13TerminatedOther
BioHorizons 0.035 Hex Driver, REF 300-377, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only, REF 300-377.
Premature wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear.
- 2007-04-13TerminatedOther
BioHorizons 0.050 Hex Driver, Regular, REF 300-350, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only
Premature Wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear.
- 2007-04-13TerminatedOther
BioHorizons 0.050 Hex Driver, Long, REF 300-351, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only
Premature Wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear.
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